[Senate Hearing 108-788]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-788

               PARENTS RAISING CHILDREN: PREMATURE BABIES

=======================================================================

                                HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON CHILDREN AND FAMILIES

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                                   ON



     EXAMINING CAUSES, RESEARCH AND PREVENTION OF PREMATURE BIRTHS

                               __________

                              May 13, 2004

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions

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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                 ______

                 Subcommittee on Children and Families

                  LAMAR ALEXANDER, Tennessee, Chairman

MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
CHRISTOPHER S. BOND, Missouri        TOM HARKIN, Iowa
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                   Marguerite Sallee, Staff Director

                 Grace A. Reef, Minority Staff Director

                                  (ii)


                            C O N T E N T S

                               __________

                               STATEMENTS

                         Thursday, May 13, 2004

                                                                   Page
Alexander, Hon. Lamar, a U.S. Senator from the State of 
  Tennessee, opening statement...................................     1
Bond, Hon. Christopher S., a U.S. Senator from the State of 
  Missouri, opening statement....................................     5
Dodd, Hon. Christopher J., a U.S. Senator from the State of 
  Connecticut, statement.........................................    33
Lugar, Hon. Richard G., a U.S. Senator from the State of Indiana, 
  prepared statement.............................................     2
Lincoln, Hon. Blanche, a U.S. Senator from the State of Arkansas, 
  prepared statement.............................................     3
Letter of support of Representatives Upton and Eshoo.............     4
Alexander, Duane F., M.D., Director, National Institute of Child 
  Health and Human Development, National Institutes of Health; 
  Peter C. Van Dyck, M.D., Associate Administrator, Maternal and 
  Child Health Bureau, Health Resources and Services 
  Administration; and Eve Lackritz, M.D., Chief, Maternal and 
  Infant Health Branch, Division of Reproductive Health, National 
  Center for Chronic Disease Prevention and Health Promotion, 
  Centers for Disease Control and Prevention.....................     7
    Prepared statements of:
        Dr. Alexander............................................    10
        Dr. Van Dyck.............................................    15
        Dr. Lackritz.............................................    20
Howse, Jennifer L., President, March of Dimes; Charles J. 
  Lockwood, M.D., Chairman, Department of Obstetrics, Gynecology, 
  and Reproductive Sciences, Yale University School of Medicine; 
  and Kelly Bolton Jordan, Memphis, TN...........................    35
    Prepared statements of:
        Ms. Howse................................................    38
        Dr. Lockwood.............................................    44
        Ms. Jordan...............................................    48

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Pediatrix Medical Group, Inc.................................    58
    Joy V. Browne, Ph.D..........................................    59
    The Association of Women's Health, Obstetric and Neonatal 
      Nurses (AWHONN)............................................    62
    American Hospital Association................................    66
    The American College of Obstetricians and Gynecologists 
      (ACOG).....................................................    66
    The Society for Maternal-Fetal Medicine......................    68
    Questions of Senator Jeffords................................    69
    Association of Maternal and Child Health Programs (AMCHP)....    70

                                 (iii)

  

 
               PARENTS RAISING CHILDREN: PREMATURE BABIES

                              ----------                              


                         THURSDAY, MAY 13, 2004

                                       U.S. Senate,
Subcommittee on Children and Families, Committee on Health, 
                            Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, in room SD-430, 
Dirksen Senate Office Building, Hon. Lamar Alexander (chairman 
of the subcommittee) presiding.
    Present: Senators Alexander, Bond, and Dodd.

                 Opening Statement of Senator Alexander

    Senator Alexander. Good morning. This hearing of the 
Subcommittee on Children and Families will come to order.
    This is another in a series of subcommittee hearings on the 
job of being a parent in America today. Last year, our 
subcommittee held six hearings focusing on support for military 
families raising children. Last month, we held a hearing on how 
workplace flexibility can help working parents raise children 
in the world today.
    This morning, I would like to turn our attention to the 
very start of being a parent--the delivery of the baby, 
particularly the delivery of some of the most vulnerable 
babies, premature babies, those born very early and very small. 
We will focus on what we can do to help lower the premature 
birth rate as well as help mothers delivering premature babies 
and the babies themselves.
    The percentage of babies born prematurely, 3 weeks or 
earlier, has risen to a national average of 12 percent, about 
one out of every eight babies. This means that 1,305 babies are 
born prematurely every day in the United States of America.
    Unfortunately, in my State of Tennessee, the rate is even 
higher. Tennessee has the fourth highest rate of preterm births 
in the country. Fourteen percent of Tennessee babies are born 
prematurely. In an average week in Tennessee, 210 babies are 
born prematurely.
    Premature babies are 14 times more likely to die in the 
first year of life. As Governor, through what we called our 
Healthy Children Initiative, Tennessee achieved the lowest 
infant mortality rate in the State's history. Unfortunately, 
these rates are on the rise again.
    Senator Dodd and I are cosponsors of a bill, S. 1726, The 
Prematurity Research Expansion and Education for Mothers who 
Deliver Infants Early, or--obviously, we have a shorter name 
for that--the PREEMIE Act. Our bill expands research into the 
causes of prematurity so that we can reduce the rate of 
premature births. Our bill also increases research and 
education on how to care for mothers who deliver prematurely 
and babies who are born prematurely.
    In the House, the PREEMIE Act is sponsored by 
Representatives Upton and Eshoo, and they have sent over a 
letter in support of this hearing we are holding today. 
Senators Lugar and Lincoln have also submitted statements of 
support. Senator Bond of Missouri is here today, and when I 
conclude in just a moment, we will hear from him.
    By unanimous consent, I ask that their letters be included 
in the record.
    By unanimous consent, I also ask that outside groups be 
given 1 week to submit statements to be included in the record 
for this hearing.
    [The prepared statements of Senators Lugar and Lincoln 
follow:]

                  Prepared Statement of Senator Lugar

    I would like to thank the Chairman, Mr. Alexander, and the 
Ranking Member, Mr. Dodd, for calling this hearing. The rise in 
premature birth throughout the country and in my own State--
despite all of our achievements in medicine--is astounding. 
Nationally, more than 480,000 babies were born preterm in 2002. 
Nearly 13 percent of Indiana's infants are born preterm and in 
half of the cases, doctors cannot identify the cause. 
Prematurity is the leading cause of infant death in the first 
month of life. Many of these infants will suffer lifelong 
health problems--such as cerebral palsy, mental retardation, 
chronic lung disease, and vision and hearing loss--and some 
will die. Reducing the number of premature births will improve 
the health of hundreds of thousands of infants born each year.
    Aside from these human costs, the financial cost of caring 
for preterm infants is enormous. The March of Dimes estimates 
that the national hospital bill for infants with a diagnosis of 
prematurity/low birthweight was $13.6 billion in 2001.
    I am pleased to be a cosponsor S. 1726, the ``PREEMIE 
Act,'' legislation that seeks to expand and coordinate research 
on the prevention of preterm birth and the most effective care 
for babies when they are born preterm.
    Along with Senator Lincoln, I am also a sponsor of another 
bill, S. 1734, the ``Prevent Prematurity and Improve Child 
Health Act,'' which seeks to improve Medicaid and SCHIP to 
reflect our current state of knowledge on preterm birth. For 
example, medical research tells us that smoking is a 
considerable risk factor for preterm and low birthweight 
infants. Our bill takes this knowledge and translates it into 
practice by ensuring that smoking cessation services and 
pharmaceuticals are available for pregnant women enrolled in 
Medicaid.
    My wife Char and I have been long-time volunteers for the 
March of Dimes and I am pleased that they are committing such 
an enormous amount of time, energy and resources into 
conquering the stubborn problem of preterm birth with their 5-
year Prematurity Campaign. Both of these bills have the 
potential to make a real difference in many lives and I hope 
that our colleagues will consider joining us in this effort.

                 Prepared Statement of Senator Lincoln

    I want to thank the Chairman and the Ranking Member for 
holding a hearing on this important issue. We are very 
fortunate to have the leadership of Senator Alexander and 
Senator Dodd on an issue as important as preterm birth. As a 
mother of twin boys, I understand the critical role of prenatal 
care in ensuring a safe delivery. I was lucky that my boys were 
delivered safely and were not premature, but not every woman is 
lucky enough to have access to the quality prenatal care that I 
did.
    I support S. 1726, the PREEMIE Act, and commend my 
colleagues for their leadership on this issue. As you may know, 
I have introduced a related bill--the Prevent Prematurity and 
Improve Child Health Act of 2003, which seeks to reduce the 
incidence of prematurity and improve the health of women of 
childbearing age and children by expanding access to health 
care. I was joined in this effort by my colleagues Senators 
Richard Lugar and Jeff Bingaman.
    The number of premature births is increasing at an alarming 
rate. According to data from the National Center for Health 
Statistics, more than 480,000 infants were born prematurely in 
2002--a 29 percent increase since 1981 and the highest level 
ever reported in the United States. Prematurity, which is 
defined as birth at less than 37 completed weeks of gestation, 
is the leading cause of infant death in the first month of 
life. Today, one in eight infants is born too early. 
Unfortunately, in my own State of Arkansas, the problem of 
preterm births is even more astounding. In 2002, nearly 13 
percent of births were preterm, ranking Arkansas 36th in the 
Nation. This is a clear wake-up call: we must take action to 
reduce the number of premature births, improving the health of 
hundreds of thousands of infants born each year.
    Premature birth can happen to any family. In fact, nearly 
half of premature births have no known cause and, in too many 
cases, families are left asking ``Why my child?'' Increasing 
our investment in uncovering the causes of preterm birth and 
ways to prevent it is essential to giving doctors, nurses and 
parents-to-be more information about having a healthy baby.
    But we do know some of the factors associated with 
increased risk of delivering too soon, including maternal age, 
multiple births, a history of preterm delivery, stress, 
infection, smoking, and drug use.
    Nationally, the number of preterm births is increasing but 
I'm proud to say that in Arkansas, we're fighting back and have 
seen the number of premature babies decrease every year since 
1999. We increased access to prenatal care for women by 
expanding Medicaid eligibility to 200 percent of the Federal 
poverty level. Unplanned pregnancies and pregnancies spaced too 
close together are risk factors for preterm birth. Through a 
Medicaid family planning waiver, Arkansas is making family 
planning services available to any woman with income below 200 
percent of poverty, whether she is eligible for Medicaid or 
not.
    Senator Lugar and I, along with Senator Bingaman, have 
introduced S. 1734, the ``Prevent Prematurity and Improve Child 
Health Act,'' to give States increased flexibility and the 
Federal resources needed to improve access to prenatal care for 
low-income pregnant women. This bill, before the Finance 
Committee, would give States new options to cover pregnant 
women under the State Children's Health Insurance Program 
(SCHIP) and to cover low-income legal immigrant pregnant women 
and children under Medicaid and SCHIP. Additionally, this bill 
tackles a major prematurity risk factor--maternal smoking--by 
improving and expanding coverage for pharmaceuticals and 
counseling to help pregnant women in Medicaid quit smoking. 
This bill also gives States the tools they need to help low-
income women avoid another risk factor for premature birth--
spacing pregnancies too close together. In recent years, a 
number of States, including Arkansas, have sought and received 
Federal permission in the form of waivers to provide Medicaid-
financed family planning services and supplies to income-
eligible uninsured residents whose incomes are above the 
State's regular Medicaid eligibility ceilings. This bill would 
make it possible for States to extend Medicaid coverage for 
family planning services without having to obtain a Federal 
waiver. Finally, some infants and children with disabilities, 
such as those born preterm, have private health insurance with 
limited benefits that do not meet their health needs. This 
legislation would allow SCHIP to serve as a wrap-around program 
for income-eligible children who need extra medical benefits, 
just as Medicaid currently does.
    There are still many unanswered questions on the causes and 
prevention of preterm birth. But with increased support for 
medical research, I am confident that we can roll back the rate 
of preterm births. And as the distinguished panel of 
researchers gathered here finds new interventions to improve 
infant birth outcomes, I will work with my colleagues here in 
the Senate to turn those research results into practice.
    [Letter of support of Representatives Upton and Eshoo 
follow:]

                                                      May 13, 2004.
Hon. Lamar Alexander,
Chairman,
Hon. Christopher Dodd, 
Ranking Member,
Subcommittee on Children and Families,
615 Hart Senate Office Building,
Washington, D.C. 20510.

    Dear Senator Alexander and Senator Dodd: As the sponsor and 
original cosponsor of the House companion measure to the PREEMIE Act, 
we are writing to commend you and thank you for your leadership on this 
vitally important public health issue. The hearing you are holding 
today on the PREEMIE Act will give much-needed public attention to the 
silent crisis of premature births in our Nation.
    As you are aware, each day 1,305 babies are born too soon, and the 
rate of preterm birth increased 27 percent between 1981 and 2001. 
Tragically, premature infants are 14 times more likely to die in their 
first year of life, and premature babies who survive may suffer 
lifelong consequences, including cerebral palsy, mental retardation, 
chronic lung disease, and vision and hearing loss. Preterm delivery can 
happen to any pregnant woman, and in nearly half of the cases, no one 
knows why.
    Underscoring the imperative to deepen our understanding of the 
causes and ways of preventing prematurity, the National Center for 
Health Statistics recently released data showing that in 2002, for the 
first time since 1958, our Nation's infant mortality rate rose. The 
Center attributes this rise to an increase in neonatal infant deaths, 
with the causes including not only birth defects but also disorders 
related to short gestation and low birth weight.
    The goals of the PREEMIE Act are to reduce the rates of preterm 
labor and delivery, promote the use of evidence-based care for pregnant 
women at risk of preterm labor and for infants born preterm, and reduce 
infant mortality and disabilities caused by prematurity. These goals 
will be met by expanding Federal research related to preterm labor and 
delivery and increasing public and provider education and support 
services.
    Again, thank you for your leadership in meeting this compelling 
public health challenge.
            Sincerely yours,
                                           Rep. Fred Upton.
                                           Rep. Anna Eshoo.
                                 ______
                                 

    Senator Alexander. I hope that today's hearing will shed 
some light on the current state of research on premature 
birth--causes, prevention, best treatment practices and more. 
Hopefully, we will learn where there are gaps in what we still 
need to work on to help lower the rate of premature births. By 
decreasing the rate of premature births, we hope to reduce 
infant mortality and disabilities caused by prematurity.
    I am looking forward to hearing from our witnesses this 
morning.
    In our first panel, three experts from our top Federal 
health agencies--the National Institutes of Health, the Centers 
for Disease Control and Prevention, and the Health Resources 
and Services Administration--are here to talk with us about 
research and programs their agencies are involved with related 
to premature birth.
    Thank you all for being with us today.
    Our second panel will include the president of the March of 
Dimes, which has taken the lead, and we will hear more about 
this effort this morning; a practicing physician and a 
researcher experienced in the field of premature births, as 
well as a mother from Tennessee who delivered a baby girl 
weighing one pound, 10 ounces when she was just under 26 weeks 
pregnant.
    Senator Dodd, who is the ranking Democratic member of this 
subcommittee, has been a longstanding supporter of children's 
issues. He will be arriving as soon as he can, but he expects 
to be here.
    And we are delighted to have with us today Senator Kit Bond 
of Missouri, who as a Governor was active in children's and 
families' issues and has carried that interest with him to the 
U.S. Senate.
    I would like to ask Senator Bond if he would like to say a 
few words now.

                   Opening Statement of Senator Bond

    Senator Bond. Thank you very much, Mr. Chairman.
    As fellow gubernatorial colleagues, we used to work 
together as Governors back in the good, old days, when we could 
give orders and things happened. It was a lot of hard work, but 
we could get some things done, and I remember well the great 
cooperation that I had with my neighbor from Tennessee when we 
were both in the Governor's office.
    Back early on in my term, I had a great interest in birth 
defects and prematurity prevention. As Governor, I was 
approached by many people who were concerned about the 
tremendous infant mortality. At that time back in the early 
seventies, if somebody had a baby under 5 pounds, you were 
really worried about it. So we went to work and secured dollars 
to fund the very fine neonatal care units at our hospitals and 
these remarkable institutions with dedicated men and women who 
serve there and are doing a tremendous job of saving low birth 
weight babies and babies with severe birth defects.
    I have seen a lot of infants like that grow to be healthy 
youngsters, and now I am getting old enough that some of them 
are young adults now. And that is a great step forward. But by 
the time I began my second term in the 1980's, I was talking 
about what a great job we were doing saving these babies, but 
the doctors and nurses said: Why don't we do something to 
reduce the incidence of birth defects and prematurity and the 
problems that bring the tiniest of infants to these very high-
tech, specialized care units--not that we don't like the units, 
but let us do them and ourselves a favor and try to keep them 
from having to go into that kind of care.
    So when I came to the Senate, I worked with colleagues on 
both sides of the aisle, with my colleague from Connecticut, 
Senator Dodd and the March of Dimes on how we deal with the 
serious and compelling health problems facing families. I have 
to apologize, because this committee, the HELP Committee, has 
very important IDEA legislation on the floor, and I am supposed 
to go over and speak. As I said, being a Senator, you cannot 
set your time anymore. Somebody calls and tells you when you 
have to be on the floor. So I am going to have to leave for the 
floor, and I would not be surprised if Senator Dodd is not 
having that same problem.
    But during the last session of Congress, working with 
Senator Dodd, we passed legislation that he and I introduced to 
renew the Federal commitment to finding the causes of birth 
defects and preventing those for which we know the causes. The 
determination of the importance of folic acid is one important 
step, but that is one of only many steps that we need to take.
    I am very proud of the important work being done by the 
National Center on Birth Defects and Developmental Disabilities 
at the CDC in this area. But I am concerned, as our chairman 
and ranking member, that Congress has not yet addressed the 
serious and growing problem of premature birth and low birth 
weight babies.
    My State of Missouri is not in quite as bad shape as 
Tennessee, but still, 12.7 percent of births are preterm--an 
increase of over 11 percent over the last decade--and that is 
troubling. Preterm labor can happen to any pregnant woman, and 
the causes of nearly half of all preterm births are unknown. It 
is difficult enough to deal with the problem when we know what 
the causes are, but when we do not know what the causes are, 
that is really a challenge.
    To address this issue, I am very happy to be a cosponsor of 
this important PREEMIE legislation. We have got to do something 
to block these acronyms, Mr. Chairman. People keep getting more 
and more ingenious in coming up with acronyms, and ``PREEMIE'' 
does sound good. It will expand Federal research into the 
causes and prevention of prematurity.
    I look forward to working with my colleagues on this 
committee and in the Senate to pass this important legislation 
as quickly as we can, if anything can happen quickly in the 
Senate these days, because I think a Federal investment is 
critical to help find the causes of premature births and gain 
more knowledge to save more babies.
    I thank the chair and look forward to hearing the witnesses 
before I have to leave.
    Senator Alexander. Thank you, Senator Bond, for your 
leadership, both as Governor and as Senator.
    Let me introduce the witnesses on the first panel, and then 
I will ask you to make your presentations. If you can summarize 
them to some extent and not take more than 10 minutes for your 
presentation, that will leave us more times for questions, and 
then we have a second panel of witnesses that we would like to 
get to.
    Dr. Duane Alexander is director of the National Institute 
of Child Health and Human Development at the National 
Institutes of Health. Much of the research of the Institute 
relates to healthy pregnancies, the delivery of healthy babies, 
and the development of healthy children.
    Dr. Alexander earned his B.S. degree at Penn State and his 
M.D. at Johns Hopkins.
    Dr. Peter Van Dyck is associate administrator of the 
Maternal and Child Health Bureau at the Health Resources and 
Services Administration. The Bureau works to promote and 
improve the health of mothers, children, and families, 
particularly those who are poor and lack access to care.
    Dr. Van Dyck earned a master of science degree in 
physiology, a medical degree from the University of Illinois, 
and a master's of public health degree in maternal and child 
health from Berkeley.
    Dr. Eve Lackritz is the chief of the Maternal and Infant 
Health Branch within the Division of Reproductive Health at the 
Centers for Disease Control. CDC addresses the problem of 
preterm births with public health surveillance, State and 
community health programs, and epidemiologic and laboratory 
research.
    Dr. Lackritz earned her M.D. from Ohio State.
    We look forward to your testimony, and why don't we begin 
with Dr. Alexander?

  STATEMENTS OF DUANE F. ALEXANDER, M.D., DIRECTOR, NATIONAL 
   INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, NATIONAL 
   INSTITUTES OF HEALTH; PETER C. VAN DYCK, M.D., ASSOCIATE 
    ADMINISTRATOR, MATERNAL AND CHILD HEALTH BUREAU, HEALTH 
RESOURCES AND SERVICES ADMINISTRATION; AND EVE LACKRITZ, M.D., 
     CHIEF, MATERNAL AND INFANT HEALTH BRANCH, DIVISION OF 
   REPRODUCTIVE HEALTH, NATIONAL CENTER FOR CHRONIC DISEASE 
 PREVENTION AND HEALTH PROMOTION, CENTERS FOR DISEASE CONTROL 
                         AND PREVENTION

    Dr. Alexander. Thank you, Mr. Chairman. Good morning. Good 
morning, Senator Bond.
    I very much appreciate the chance to be here to talk about 
the critical health challenge of prematurity and very much 
appreciate also your interest in this issue and your 
championship of it.
    Last year during the celebration of the 40th anniversary of 
the National Institute of Child Health and Human Development, 
we took stock of our efforts to advance research in fields like 
prematurity and infant mortality that fall within the 
Institute's mission. Infant mortality is a major index of a 
Nation's health.
    Since the founding of NICHD, the infant mortality rates in 
the United States have dropped by more than 70 percent, from 24 
to a low of 6.8 per 1,000 live births in 2001, with much of 
this decline resulting from NICHD-sponsored research on care of 
low birth weight infants, on Sudden Infant Death Syndrome and 
other factors.
    For example, research efforts of NICHD and other institutes 
resulted in survival rates for very premature infants with 
respiratory distress syndrome going from 5 percent in the 
1960's to more than 95 percent today, an incredible change due 
to advances in respiratory technologies and availability of 
prenatal steroids and replacement lung surfactant.
    Sadly, even with these important accomplishments, we are 
still far from solving the problem of prematurity, and our 
improvements in infant mortality have come about in spite of, 
not because of, what has happened with prematurity rates, which 
have actually worsened.
    Premature birth before 37 weeks of gestation poses great 
risks to the infant. In addition to mortality, it accounts for 
one in five children born with mental retardation, one in three 
who has some visual impairment, and almost half of the babies 
with cerebral palsy.
    For the mother, not only is preterm labor a leading cause 
of hospitalization for a pregnant woman, but she faces a 
greatly increased risk of having a second premature infant in 
the future.
    Few other medical challenges fall so squarely within the 
mission of NICHD, which is ``to assure that every individual is 
born healthy and wanted, that women suffer no adverse 
consequences from the reproductive process, and that all 
children reach adulthood free of disease and disability and 
able to achieve their full potential for a healthy and 
productive life.''
    We are focusing on prematurity using every mechanism at our 
disposal, including investigator-initiated grant applications 
from scientists around the country, our own requests for grant 
proposals in specific areas, intramural research in our own 
laboratories and clinics, conferences and workshops, and most 
of all in our multicenter networks in Maternal-Fetal Medicine, 
which deliver about 120,000 babies a year, and our Neonatal 
Network, which cares for about 60,000 babies every year.
    With these numbers of pregnant women and infants that we 
are able to care for at these hospitals, staffed by some of the 
leading clinician-researchers in the field working 
collaborative, we have an opportunity to quickly and thoroughly 
test new preterm delivery prevention and management strategies.
    Until recently, tested strategies to prevent preterm birth 
in high-risk women failed to produce effective, reliable 
results because too few patients were studied, and conditions 
were not well-controlled. The Maternal-Fetal Medicine Network 
was established to overcome these problems. This network, in 
one of the few concrete breakthroughs on this tremendously 
difficult front, published in the New England Journal of 
Medicine in 2003, our network scientists demonstrated that 
weekly injections of 17-alpha-hydroxy-progesterone can reduce 
preterm birth by one-third among women at increased risk of 
preterm delivery because they had previously had a preterm 
delivery.
    Not only were the women who were treated with progesterone 
one-third more likely to carry their babies to term, but their 
infants also had a much lower rate of life-threatening 
complications.
    The 463 women involved in this study were considered to be 
at high risk for preterm birth because they had had a previous 
preterm delivery, at an average of about 31 weeks instead of 
the normal 40. As in many clinical trials, some of the women 
enrolled received the hormone being tested, the progesterone, 
and some received a placebo injection.
    The reduction in preterm birth that occurred in African 
American women as well as nonAfrican American women was so 
dramatic that our scientists terminated the study early so we 
could make the results available to practitioners.
    Shortly after, a committee of the American College of 
Obstetricians and Gynecologists notified its members of this 
success and recommended that women who had had a previous 
preterm delivery be considered for treatment with progesterone.
    Now let me talk for just a minute about some other efforts 
in preventing preterm labor. Over the years, we have supported 
a number of studies to examine the effectiveness of various 
proposed interventions for preterm labor, and this research has 
had some surprises.
    For instance, studies have shown that bed rest, which until 
very recently was the most common preventive approach, was not 
effective in preventing preterm labor or delaying preterm 
birth, and in some cases may have actually made the situation 
worse.
    Other studies have examined the effectiveness of different 
drugs in suppressing contractions early in preterm labor, 
although no consistently effective treatment has yet been 
identified.
    Yet another Maternal-Fetal Medicine Network trial 
demonstrated that home uterine activity monitoring, an 
expensive and highly touted regimen claimed to reduce preterm 
delivery, was completely ineffective for this purpose, thereby 
saving money and wasted effort by ending this useless practice.
    Many NICHD-supported studies have been trying to answer the 
basic question of why women with no known risks experience 
preterm labor. During the course of these studies, researchers 
explored the relationship between a condition called bacterial 
vaginosis and preterm labor. In 1999, we completed a large 
study that recruited pregnant women who had asymptomatic 
bacterial vaginosis to explore this association and the results 
of antibiotic treatment for it. This study found no difference 
in preterm labor or delivery between women who received an 
antibiotic and women who received a placebo, and then we 
stopped the growing practice of treating women who had 
asymptomatic bacterial vaginosis with antibiotics 
unnecessarily.
    Scientists in other NIH institutes are looking for other 
clues to the cause of preterm labor and treatment for premature 
infants. For example, the National Institute of Environmental 
Health Sciences is supporting research on whether exposure to 
certain environmental contaminants during pregnancy relates to 
preterm birth.
    And the National Heart, Lung, and Blood Institute is 
supporting studies on prevention of chronic lung disease in 
surviving premature infants.
    In addition, NICHD's newest intramural branch, the 
Perinatology Research Branch, is devoted to the study of 
preterm birth and its consequences. Among other developments, 
this branch has provided evidence that many premature newborns 
were critically ill prior to birth due to intrauterine 
infection, and is exploring the role of intentional selective 
premature delivery in order to help these babies receive 
earlier treatment in order to survive.
    We were able to rule out bacterial vaginosis as a direct 
cause of prematurity and, building on the progress that we have 
made, we will continue to conduct more research on 
understanding the causes of this condition, whether there is an 
identifiable subgroup of infected women who are particularly at 
risk, how we can prevent and treat prematurity, and further 
work on how best to manage or treat newborns who have been born 
prematurely.
    We thank you for this opportunity to discuss NICHD's 
research in prematurity and for your interest in this topic, 
and I will be glad to answer any questions later.
    Thank you.
    Senator Alexander. Thank you.
    [The prepared statement of Dr. Alexander follows:]

             Prepared Statement of Duane F. Alexander, M.D.

    Last year, during our celebration of the 40th anniversary of the 
Institute, we had an opportunity to take stock of our efforts to 
advance research in the fields that fall within our mission. Infant 
mortality is a major index of a Nation's health, yet the infant 
mortality rate in the United States remains far higher than it should 
be, given the advantages we have compared to many countries with lower 
rates. We were gratified to realize that since the founding of NICHD, 
infant mortality rates in the United States have dropped more than 70 
percent (to an all-time low of 6.8 per 1,000 live births in 2001), with 
much of this decline resulting from NICHD-sponsored research on care of 
low birth weight infants, Sudden Infant Death Syndrome, and other 
factors. For example, resulting from the research efforts of NICHD and 
other Institutes, survival rates for very premature infants with 
respiratory distress syndrome have gone from 5 percent in the 1960s to 
95 percent today, due to advances in respirator technologies and the 
availability of replacement lung surfactant.
    Sadly, even with these important accomplishments, we are still far 
from solving the problem of prematurity. Preterm birth (before 37 weeks 
of gestation) poses great risks to the infant. At least one in eight 
infants about 476,000--is born prematurely in the United States each 
year. Over the last 20 years, preterm birth in this country has 
actually increased by 21 percent. Preterm birth is the leading cause of 
death among African-American infants, contributing substantially to 
racial and ethnic health disparities in infant mortality, and is one of 
the top causes of all neonatal and infant deaths. In addition, preterm 
babies are more likely to have long-term health problems, such as a 
higher incidence of developmental disabilities. Premature delivery 
accounts for one of five children born with mental retardation, one of 
three who have some visual impairment, and almost half of those babies 
with cerebral palsy. Over the longer term, for the baby, for reasons we 
cannot explain, preterm birth carries with it an increased risk for 
cardiovascular disease and diabetes as an adult. For the mother, not 
only is preterm labor a leading cause of hospitalization of women, but 
she faces a greatly increased risk of delivering prematurely in the 
future.
    Few other medical challenges fall so squarely within the mission of 
the NICHD, which is ``to assure that every individual is born healthy 
and wanted, that women suffer no adverse consequences from the 
reproductive process, and that all children have the opportunity to 
fulfill their potential for a healthy and productive life unhampered by 
disease or disability.'' We are focusing on prematurity using every 
mechanism at our disposal, including investigator-initiated grant 
applications from scientists across the country, our own requests for 
grant proposals in specific areas, conferences and workshops, and most 
of all, our multi-center networks the Maternal-Fetal Medicine Units, 
which deliver about 120,000 babies each year, and the Neonatal Network, 
which cares for about 60,000 babies every year. As you can see, the 
numbers of pregnant women and infants we are able to care for at these 
hospitals, staffed by some of the leading clinician-researchers in the 
field working collaboratively, gives us an opportunity to quickly and 
thoroughly test new preterm delivery prevention and management 
strategies.
    Until recently, most previously tested strategies to prevent 
preterm birth in high-risk women failed to produce effective, reliable 
results because too few patients were studied and conditions were not 
well controlled. The Maternal-Fetal Medicine Network was established to 
overcome these problems. In one of the few concrete breakthroughs on 
this tremendously difficult front, published in the New England Journal 
of Medicine in 2003, we reported that our scientists who participate in 
the MFMU network had demonstrated that weekly injections of 17-hydroxy-
progesterone, can reduce preterm birth by one-third among women at 
increased risk of preterm delivery because they had previously had a 
preterm delivery. Not only were the women treated with progesterone 30 
percent more likely to carry their babies to term, their infants also 
had a much lower rate of life-threatening complications. The 463 women 
involved in the study were considered to be at high risk for preterm 
birth because they each had previously spontaneously delivered a baby 
early, at an average of about 31 weeks. As in many clinical trials, 
some of the women enrolled received the hormone being tested (the 
progesterone), while some received a placebo injection. The reduction 
in preterm birth for African American women as well as non-African 
American women--was so dramatic that the scientists halted the study 
early to make the results available to practitioners. Shortly 
thereafter, a committee of the American College of Obstetricians and 
Gynecologists notified its members of the success of this trial, 
recommending that women who had had a previous preterm delivery be 
considered for treatment with progesterone.
    Let me talk for a moment about preventing preterm labor, one of the 
best ways to reduce the numbers of preterm births. Over the years, we 
have supported a range of studies to examine the effectiveness of 
various preventive measures for preterm labor, and this research has 
revealed some surprises. For instance, studies have shown that bed 
rest, which until very recently was the most common preventive 
approach, was not effective in preventing preterm labor or in delaying 
preterm birth. In some cases, bed rest may have actually made the 
situation worse. One possible explanation for these findings may be 
that active pregnant women are better able to expand their blood 
volume, which is necessary for a successful, full-term pregnancy. Other 
studies have examined the effectiveness of different drugs in 
suppressing uterine contractions early in preterm labor, although no 
effective treatment has yet been identified. Yet another Maternal-Fetal 
Medicine Network trial demonstrated that Home Uterine Activity 
Monitoring, an expensive, highly touted regimen claimed to reduce 
preterm delivery, was completely ineffective for this purpose, thereby 
saving money and wasted effort by ending this useless practice.
    Many NICHD-supported studies have been trying to answer the basic 
question of why women with no known risks experience preterm labor. 
During the course of these studies, researchers noted a relationship 
between bacterial vaginosis and preterm labor. In 1999, NICHD completed 
a large study that recruited pregnant women who had asymptomatic 
bacterial vaginosis to explore this possible association and results of 
treatment for it. Although the study found no difference in preterm 
labor between women who received an antibiotic and women who received 
the placebo, the research provided important clues about other possible 
treatments. It also stopped the growing practice of treating women who 
have asymptomatic bacterial vaginosis with antibiotics unnecessarily. 
Scientists at other institutes are looking for other clues to the cause 
of preterm labor. For example, the National Institute of Environmental 
Health Sciences is supporting research on whether exposure to certain 
environmental contaminants during pregnancy relates to preterm birth.
    In addition, NICHD's newest intramural branch, the Perinatology 
Research Branch, is devoted to the study of premature birth and its 
consequences. Among other developments, the Branch has provided 
evidence that many premature newborns were critically ill prior to 
birth due to intrauterine infection, and is exploring the role of 
premature delivery in order to help these babies receive earlier 
treatment in order to survive.
    We were able to rule out bacterial vaginosis as a direct cause of 
prematurity, and building on the progress we have made, we will conduct 
more research on understanding the causes of this condition, how we can 
prevent and treat prematurity in pregnant women, and further work on 
how best to manage or treat newborns who have been born prematurely.
    Thank you for the opportunity to discuss NICHD's research on 
prematurity and for your interest in this important topic. I am happy 
to answer any questions you may have.

    Senator Alexander. Dr. Van Dyck?
    Dr. Van Dyck. Thank you. Good morning, Mr. Chairman, 
Senator Bond.
    I am Peter Van Dyck, the director of Maternal and Child 
Health in the Health Resources and Services Administration. I 
want to thank you for the opportunity to testify today about 
prematurity and the related HRSA programs and activities.
    HRSA, or the Health Resources and Services Administration, 
is often referred to as ``the access agency'' that provides 
health care and social services to millions of low-income 
Americans, many of whom lack health insurance and live in 
remote rural communities and inner-city areas where health care 
services are scarce.
    We work in partnership with States and local communities. 
In fact, the bureau that I direct, the Maternal and Child 
Health Bureau, has a long history of working toward reducing 
prematurity and low birth weight as we strive to improve the 
health of our Nation's mothers and children.
    We recognize that low birth weight and preterm birth 
constitute a significant and costly health problem for this 
Nation. Our efforts in this area include various programs and 
initiatives.
    One program that has had a significant impact on 
prematurity is the Maternal and Child Health Block Grant, which 
is authorized by Title V of the Social Security Act. All of the 
Title V Block Grants issued through HRSA's Maternal and Child 
Health Bureau address aspects of prematurity and stipulate that 
grantees are required to submit annual performance measures.
    For the block grant, national core performance measures are 
collected from each State. Some pertain to prematurity, which 
include the percent of very low birth weight infants among all 
live births in each State as well as the percent of very low 
birth weight infants who are delivered at facilities that are 
capable of delivering high-risk mothers and neonates.
    Approaches to reducing prematurity vary throughout the 
States from direct care to enabling services to infrastructure 
building, the building of the public health system, and each 
State tracks annually performance goals that include preterm 
infants as well as related performance measures such as 
increasing early access to prenatal care and decreasing the 
disparate ratio of black-white infant mortality rates.
    Based upon the specific needs of their State, these 
programs also develop and report on individual State 
performance measures targeting low birth weight, preterm birth 
and infant mortality. For example, Michigan measures the 
percent of preterm births; Delaware measures the percent of low 
birth weight black infants among all live births to black 
women, and New Jersey reports the percentage of black 
nonHispanic preterm infants.
    Another HRSA program that deals with prematurity is the 
Healthy Start Program. Healthy Start supports 114 projects 
located in 96 communities across the Nation that have excessive 
rates of prematurity, low birth weight and infant mortality.
    Healthy Start strives to institute the best community-
oriented methods to assure that high-risk pregnant women and 
their infants gain early access to necessary services during 
pregnancy and are followed through a continuum of care until 2 
years postdelivery or postpartum.
    This program emphasizes outreach, case management, 
screening and referral for perinatal depression, and health 
education interventions to reduce risk factors such as smoking, 
alcohol and substance abuse. Selected projects are also 
examining interventions to address interconceptional care for 
women and infants identified at high risk following delivery to 
prevent future occurrences of these adverse pregnancy outcomes 
and optimize the development of the low birth weight/preterm 
infant over the next 2 years.
    HRSA also supports a number of research projects that 
address factors associated with preterm birth or relevant 
clinical practices. Multiple projects are using a new type of 
analysis to gain a better understanding of how multiple levels 
of influence--community or neighborhood factors as well as 
individual factors--are associated with adverse outcomes in 
pregnancy.
    For instance, several investigators are using multilevel 
hierarchical modeling to examine community-level factors 
associated with preterm birth, particularly the racial/ethnic 
disparity in rates of preterm delivery.
    A study on ``Assessing the Stress and Preterm Birth/Low 
Birth Weight Relationship,'' because strenuous working 
conditions and occupational fatigue in pregnancy have been 
associated with preterm delivery and low birth weight among 
working women, will test the extent to which occupational 
stressors vary by race and ethnicity and how stressors, 
including racial discrimination, impact the risk for preterm 
birth and/or low birth weight. By investigating the 
relationships between stress during pregnancy, placental 
corticotrophin-relating hormone, and antenatal leave, this 
study will help identify the risks and protective factors that 
contribute to pregnancy outcomes among working women.
    HRSA also supports and manages the Departmental Advisory 
Committee on Infant Mortality. This is the national advisory 
committee established to advise the Secretary of Health and 
Human Services concerning the issue of infant mortality, 
including such causes as low birth weight/preterm birth, and 
the most appropriate steps that might be taken to address this 
problem. It also provides expert advice on how best to 
coordinate the variety of Federal, State, local and private 
programs and efforts underway that are designed to deal with 
health and social problems impacting on infant mortality.
    We are also proud of the fact that HRSA's community health 
centers have fewer low birth weight babies than the national 
average. As part of the HRSA strategy to close the gap in 
health disparities, HRSA-supported health centers will develop 
a cutting-edge process to improve and change their systems of 
delivering perinatal care. The aims of this Perinatal/Patient 
Safety Pilot Collaborative are to develop comprehensive 
perinatal system change interventions based on the Care Model. 
The Care Model emphasizes evidence-based, planned, integrated 
collaborative care that will generate major improvements in 
process and outcome measures for perinatal care and will 
establish and document the safety of the perinatal system for 
both infants and mothers.
    HRSA's Bureau of Primary Health Care also has a best 
practices project specifically addressing low birth weight. It 
is a study to identify programs, policies and procedures of 
selected health centers that resulted in lowering the rates of 
low birth weight among racial/ethnic minority infants. A 
secondary aim of the project was to distinguish practices that 
could be replicated in other supported health centers with the 
hope of reducing low birth weights in those centers as well, 
particularly those in communities of color.
    In the next 6 to 9 months, the results of this study will 
be disseminated via presentations at professional meetings and 
in publications in peer-reviewed journals.
    The committee asked us specifically to address the Health 
and Human Services Interagency Coordinating Council on Low 
Birth Weight and Preterm Birth. That title is much too long to 
even develop an acronym for.
    HRSA co-chairs and staffs this coordinating council. In 
response to recommendations of the Advisory Committee on Infant 
Mortality, Secretary Thompson asked HRSA and the National 
Institutes of Health to organize this council. I am proud to 
serve as co-chair of this council along with my colleague Dr. 
Duane Alexander, Director of the National Institute for Child 
Health and Human Development--and I might mention as well that 
Dr. Lackritz is an important member of that committee as well.
    This group includes representatives from 12 agencies and/or 
offices in the Department and two liaison members from the 
Secretary's Advisory Committee on Infant Mortality. And the 
staff work is supported by HRSA.
    The purpose of the Coordinating Council is to galvanize 
multidisciplinary research, scientific exchange, policy 
initiatives, and collaboration among the Department's agencies 
and to assist in targeting efforts to achieve the greatest 
advances toward the national goal of reducing infant mortality.
    In particular, Secretary Thompson requested the development 
of a Department-wide research agenda on low birth weight and 
preterm birth, which we know are major contributors or major 
factors for infant mortality. Subsequently, Deputy Secretary 
Allen expanded the charge of the committee by requesting us to 
focus attention to racial/ethnic disparities and to Sudden 
Infant Death Syndrome as contributors to infant mortality.
    This Coordinating Council is working in conjunction with 
the Advisory Committee on Infant Mortality to further efforts 
to formulate recommendations for a coordinated research agenda 
for the Secretary.
    Clearly, challenges for the Coordinating Council include 
efforts to assure adequacy of data on low birth weight and 
preterm births, uncovering new knowledge and developing a 
coordinated research agenda on preterm birth and low birth 
weight, and delivering and financing relevant health care.
    Currently, the Council is compiling an ``Inventory of 
Research and Databases Pertaining to Low Birth Weight and 
Preterm Birth and Sudden Infant Death Syndrome.'' This is a 
compilation of current and planned activities within the 
department that address preterm birth and low birth weight.
    Then, we will use this information to examine gaps and 
identify priorities for future research addressing these 
issues.
    Many of our programs at HRSA, especially those that provide 
direct and enabling services to women, provide a variety of 
education and training opportunities for providers concerned 
with preterm labor, high-risk pregnancy, and risk factors. We 
have taken a proactive approach to reducing the risk of preterm 
labor and other adverse perinatal outcomes including depression 
and tobacco use during pregnancy.
    By partnering with Federal, State and local governments as 
well as the public and private sectors, as well as professional 
and faith-based organizations, HRSA provides leadership in 
improving access to and improving the quality of health care 
and services for millions of Americans. We are hard at work 
identifying and translating into everyday practice across the 
Nation the very best evidence-based interventions to overcome 
barriers to the Nation's health care.
    Thank you for the opportunity to appear before the 
committee and share with you some of HRSA's activities.
    Senator Alexander. Thank you, Dr. Van Dyck.
    [The prepared statement of Dr. Van Dyck follows:]

             Prepared Statement of Peter C. Van Dyck, M.D.

    Good morning, Mr. Chairman and Members of the Committee. I am Dr. 
Peter Van Dyck, the Health Resources and Services Administration's 
Associate Administrator for the Maternal and Child Health Bureau in the 
Department of Health and Human Services. Thank you for the opportunity 
to testify today about prematurity and the related HRSA programs and 
activities.
    The Health Resources and Services Administration (HRSA)--often 
referred to as the ``access'' agency--provides health care and social 
services to millions of low-income Americans, many of whom lack health 
insurance and live in remote rural communities and inner-city areas 
where health care services are scarce. We work in partnership with 
States and local communities. The Bureau I direct, the Maternal and 
Child Health Bureau, has a long history of working towards reducing 
prematurity and low birth weight as we strive to improve the health of 
our Nation's mothers and infants.
    We recognize that low birth weight and preterm birth constitute a 
significant and costly health problem for this Nation. Our efforts in 
this area include various programs and initiatives.
    1. One program that has a significant impact on prematurity is the 
Maternal and Child Health Block Grant authorized by Title V of the 
Social Security Act. All Title V Block Grants, funded by Title V and 
issued through HRSA's Maternal and Child Health Bureau address aspects 
of prematurity and stipulate that grantees are required to submit 
annual performance measures. For the block grant, national core 
performance measures are collected. Pertaining to prematurity, these 
include:
     Percent of very low birth weight infants among all live 
births.
     Percent of very low birth weight infants delivered at 
facilities for high-risk deliveries and neonates.
    Approaches to reducing prematurity vary throughout the States from 
direct care to enabling services to infrastructure building. Each State 
tracks annually performance goals that include preterm infants as well 
as related performance measures such as increasing early access to 
prenatal care and decreasing the disparate ratio of black-white infant 
mortality rates. Based upon the specific needs of their State, these 
programs also develop and report on individual State performance 
measures targeting low birth weight, preterm birth, and infant 
mortality. Some examples of specific State performance measures 
include: Michigan which measures the percent of preterm births; 
Delaware which measures the percent of low birth weight black infants 
among all live births to black women; and New Jersey which reports the 
percentage of black non-Hispanic preterm infants.
    2. Another HRSA program that deals with prematurity is ``The 
Healthy Start'' program. Healthy Start supports 114 projects located in 
96 communities across the Nation which have excessive rates of 
prematurity, low birth weight and infant mortality. Healthy Start 
strives to institute the best community-oriented methods to assure that 
at-risk pregnant women and their infants gain early access to necessary 
services during pregnancy and are followed through a continuum of care 
until 2 years post-delivery. This program emphasizes outreach, case 
management, screening and referral for perinatal depression and health 
education interventions to reduce risk factors such as smoking, alcohol 
and substance abuse. Selected projects are also examining interventions 
to address interconceptional care for women and infants identified as 
high-risk following delivery, to prevent future occurrences of these 
adverse pregnancy outcomes and optimize the development of the low 
birth weight/preterm infant over the next 2 years.
    3. HRSA supports the African American-Focused Risk Reduction 
component of the Department's Closing the Health Gap Initiative on 
Infant Mortality. This is supported with funding from the Healthy Start 
program in conjunction with funds from the Department's Office of 
Minority Health. The goal is to reduce African American infant 
mortality due to low birth weight/preterm birth and Sudden Infant Death 
Syndrome (SIDS), the primary areas of infant mortality disparities for 
the African American population. HRSA will pilot projects in four 
States selected on the basis of having significant African American 
births and high infant mortality rates due to low birth weight/preterm 
births and SIDS. South Carolina, Michigan, Mississippi and Illinois 
will implement pilot projects in one to two communities within each 
State that: (1) build on existing activities that contribute to infant 
mortality reduction; and (2) employ evidence-based interventions that 
could contribute to reductions in low birth weight/preterm births. 
Awards are expected to be made this summer.
    4. HRSA also supports a number of research projects that address 
factors associated with preterm birth or relevant clinical practices:
     Multiple projects are using a new type of analysis to gain 
a better understanding of how multiple levels of influence--community 
or neighborhood factors as well as individual factors--are associated 
with adverse outcomes in pregnancy. For instance:
     Several investigators are using Multi-Level Hierarchical 
Modeling to Examine Community-Level Factors Associated with Preterm 
Birth, particularly the racial/ethnic disparities in rates of preterm 
delivery.
     Another study is investigating Modifiable Neighborhood-
Level Factors and Low Birth Weight: This research project seeks to 
identify modifiable neighborhood level factors that are associated with 
intrauterine growth retardation and preterm birth in Louisiana during 
1997-2000. The study will use several data sets, including the 
Louisiana birth certificate database and the Pregnancy Risk Assessment 
Monitoring System (PRAMS) survey for individual-level variables, and 
the U.S. census and various State health department databases for 
neighborhood level variables. The analysis will assess the 
relationships between neighborhood factors and pregnancy outcomes, and 
measure the extent to which the effects of the neighborhood factors are 
mediated by individual level biologic and behavioral factors.
     Assessing the Stress and Preterm Birth/Low Birth Weight 
Relationship: Strenuous working conditions and occupational fatigue in 
pregnancy have been associated with preterm delivery and low birth 
weight among working women. This study will test the extent to which 
occupational stressors vary by race/ethnicity and how stressors 
(including racial discrimination) impact the risk for preterm birth 
and/or low birth weight. By investigating the relationships between 
stress during pregnancy, placental corticotrophin releasing hormone 
(CRH) and antenatal leave, this study will help identify the risks and 
protective factors that contribute to pregnancy outcomes among working 
women.
     Collaborative Ambulatory Research Network: Using a network 
of practicing obstetrician-gynecologists, this project assesses current 
practice patterns, the relevant knowledge base and opinions around 
various issues related to maternal and fetal health. The findings will 
have implications for changes in provider education and practice.
    In addition, HRSA is involved in translating Research into Policy 
and Programs. Initial work will focus on Women's Periodontal Health and 
Pregnancy Outcomes. A forum, planned for Fall 2004, will summarize the 
evidence around periodontal disease and preterm birth and identify 
relevant provider, system, and community actions for policy and program 
development.
    5. HRSA supports and manages the Departmental Advisory Committee on 
Infant Mortality (ACIM). This is the national advisory committee 
established to advise the Secretary of HHS concerning the issue of 
infant mortality, including such causes as low birth weight/preterm 
birth, and the most appropriate steps that might be taken to address 
this problem. It also provides expert advice on how best to coordinate 
the variety of Federal, State, local and private programs and efforts 
underway that are designed to deal with health and social problems 
impacting on infant mortality.
    6. We are proud of the fact that HRSA's health centers have fewer 
low birth weight babies than the national average. We can improve on 
that at the primary, community health level. As part of the HRSA 
strategy to close the gap in health disparities, HRSA-supported health 
centers will develop a cutting edge process to improve and change their 
systems of perinatal care. This initiative will be a part of the 
Perinatal/Patient Safety Pilot Collaborative. The aims of the Pilot 
Collaborative are to develop comprehensive perinatal system change 
interventions based upon the Care Model (which emphasizes evidence 
based, planned, integrated collaborative care) that will:
     Generate major improvements in process and outcome 
measures for perinatal care, for example, decreased infant mortality 
disparity for African Americans and decreased rates of maternal and 
infant HIV transmission, low birth weight/preterm infants and sudden 
infant death syndrome; and
     Establish and document the safety of the perinatal system 
for both infants and mothers. HRSA's Bureau of Primary Health Care also 
has a ``best practices'' project specifically addressed to low birth 
weight. It's a study to identify programs, policies and procedures of 
selected health centers that resulted in lowering the rates of low 
birth weight among racial/ethnic minority infants. A secondary aim of 
the project was to distinguish practices that could be replicated in 
other supported health centers with the hope of reducing low birth 
weights in communities of color. In the next 6 to 9 months, the results 
of this study will be disseminated via presentations at professional 
meetings and through publications in peer-reviewed journals.
    The committee asked us specifically to address the Health and Human 
Services (HHS) Interagency Coordinating Council on Low Birth Weight and 
Preterm Birth. HRSA co-chairs and staffs this coordinating council. In 
response to recommendations of the Advisory Committee on Infant 
Mortality (ACIM), Secretary Thompson asked HRSA and the National 
Institutes of Health (NIH) to organize this HHS Interagency 
Coordinating Council. I'm proud to serve as co-chair along with Dr. 
Duane Alexander, Director of NIH's National Institute of Child Health 
and Human Development. The group includes representatives from 12 
agencies and/or offices in the Department and 2 liaison members from 
the ACIM. The staff work for the Coordinating Council is being 
supported by HRSA.
    The purpose of the Coordinating Council is to galvanize 
multidisciplinary research, scientific exchange, policy initiatives, 
and collaboration among the Department's agencies and to assist in 
targeting efforts to achieve the greatest advances toward the national 
goal of reducing infant mortality. In particular, Secretary Thompson 
requested the development of a department-wide research agenda on low 
birth weight and preterm birth, major contributors to infant mortality. 
Subsequently, Deputy Secretary Allen expanded the charge by requesting 
the Coordinating Council to include in its focus attention to racial/
ethnic disparities and to Sudden Infant Death Syndrome (SIDS) as 
contributors to infant mortality.
    The Coordinating Council is working in conjunction with the 
Advisory Committee on Infant Mortality to further efforts to formulate 
recommendations for a coordinated research agenda for the Secretary. 
Challenges for the Coordinating Council include efforts to assure 
adequacy of data on low birth weight and preterm births, uncovering new 
knowledge and developing a coordinated research agenda on preterm 
birth/low birth weight, and delivering and financing relevant health 
care. Currently, the Coordinating Council is compiling an ``Inventory 
of Research and Databases Pertaining to Low Birth Weight and Preterm 
Birth and Sudden Infant Death Syndrome.'' This is a compilation of 
current and planned activities within the Department that address 
preterm birth and low birth weight. The Coordinating Council will use 
this information to examine gaps and identify priorities for future 
research addressing these issues.
    The Coordinating Council is also contributing to the research 
coordination component of the HHS initiative mentioned earlier, 
``Closing the Health Gap Initiative on Infant Mortality'', in two ways:
     The group has broadened its task to identify HHS research 
and programmatic activities pertaining to low birth weight/preterm 
birth prevention in African Americans and Sudden Infant Death Syndrome 
(SIDS) Prevention in African Americans and American Indian/Alaska 
Natives.
     The group was asked to identify evidence-based 
interventions that can contribute to reductions in SIDS, reductions in 
low birth weight/preterm births, and infant mortality associated with 
low birth weight/preterm births. In its deliberations, the group 
discussed interventions that have been shown to be effective through a 
systematic search and review of the best available scientific evidence. 
Overall, the scientific literature reveals few successful interventions 
to prevent low birth weight/preterm births, although there are 
confirmed interventions that improve the survival of these infants. The 
interventions that the Coordinating Council identified will be utilized 
in the implementation of future health disparities initiatives.
    Many of our programs at HRSA, especially those that provide direct 
and enabling services to women, provide a variety of education and 
training opportunities for providers concerning preterm labor, high-
risk pregnancy, and risk factors. We have taken a proactive approach to 
reducing the risk of preterm labor and other adverse perinatal 
outcomes, including depression and tobacco use during pregnancy. 
Through a cooperative agreement with the American College of 
Obstetricians and Gynecologists, we have worked to educate obstetric 
and women's health providers to be able to recognize and address the 
critical public health issues associated with these events.
    By partnering with Federal, State and local governments, as well as 
the public and private sectors and professional and faith-based 
organizations, the Health Resources and Services Administration 
provides leadership in improving access to and improving the quality of 
health care and services for millions of Americans. We are hard at work 
identifying and translating into everyday practice across the Nation 
the very best evidence-based interventions to overcome barriers to the 
Nation's health care.
    Thank you for the opportunity to appear before this committee and 
summarize HRSA's activities that address prematurity. I would be happy 
to answer your questions.

    Senator Alexander. Dr. Lackritz?
    Dr. Lackritz. Thank you. Good morning, Mr. Chairman, and 
thank you for this opportunity to join you today to discuss one 
of the most devastating health issues facing women, children, 
and families in America today.
    I am from CDC. I am a Commissioned Officer in the U.S. 
Public Health Service, and I am a pediatrician. And, like all 
pediatricians across the country, I have spent years working on 
hospital wards combatting this problem of prematurity. But all 
too often, I have had to inform parents that their tiny baby 
had brain damage, or debilitating handicaps, or would not be 
able to survive, all because they were born too soon.
    Now that I am at CDC, I can see the toll that prematurity 
is taking on the entire Nation. This epidemic of prematurity is 
the second leading cause of death among infants. It is the 
leading cause of death among African American infants. And it 
is the leading cause of numerous disabilities, including mental 
retardation, cerebral palsy, blindness, and lung disease.
    We as a Nation cannot afford to lose this battle that is so 
critical to the lives of these babies. The issue before us here 
today is whether we can learn how to prevent babies from being 
born too soon, prevent this death and disability, and prevent 
the toll that prematurity takes on our Nation's families.
    I will outline now how CDC, with all of our governmental 
and nongovernmental partners, formulates a prevention response 
to prematurity. We use four basic actions.
    First, CDC conducts monitoring and surveillance for 
prematurity. It is a direct parallel with CDC's work in 
tracking infectious diseases. These monitoring systems provide 
critical information about how many babies are born premature. 
We identify risk factors. It enables us to track trends and to 
find key opportunities for where to focus prevention.
    One of CDC's most important monitoring system for 
prematurity is called PRAMS, the Pregnancy Risk Assessment 
Monitoring System. PRAMS supports 31 States. It asks a sample 
of women who have recently delivered babies about most of the 
major issues that affect prematurity risk, from prenatal care 
to obesity, stress, physical abuse, and alcohol and tobacco 
use. PRAMS has been an invaluable resource to States. It helps 
them define how to direct their programs and their policies.
    These health monitoring systems like PRAMS provide data for 
action. CDC's second major role is to provide direct assistance 
to States and Tribes and local health departments and 
communities on how to analyze and use data to make important 
decisions for local policy and programs.
    CDC now has 16 epidemiologists physically located in State 
health departments and in the Indian Health Service 
specifically focused on maternal-infant health.
    We also support community-driven programs that promote 
innovative prematurity programs that are in tune with local 
needs and cultures, such as Healthy African American Families 
in Los Angeles, the REACH program in Michigan and California--
REACH stands for Racial and Ethnic Approaches to Community 
Health--and CityMatCH. CDC resources help those communities in 
greatest need to promote awareness of prematurity and help 
reduce these racial and ethnic disparities.
    CDC's third role is to move research to action. There have 
been promising new discoveries such as NIH's study of 
progesterone injections, but we still do not know if women will 
accept these painful weekly injections or pay for preventive 
treatment or be able to attend weekly clinic appointments. CDC 
takes those hard steps with States and communities to move 
scientific discoveries to widespread public health practice and 
then measures the impact that they make.
    CDC's fourth major role is public health research in the 
field and to respond to new and emerging threats to infant 
health and prematurity. We learned about the use of a chewing 
tobacco product called Iq'mik, which is widely used among 
Alaska Natives in the Yukon Delta region. The way it is 
prepared results in free-basing of nicotine and results in 
incredibly high levels of nicotine in the blood.
    Analysis of CDC's PRAMS data found that well over 60 
percent of women were using this product during their 
pregnancies. CDC scientists responded by initiating a field 
investigation to assess this risk in pregnant women and helped 
develop a prevention response.
    In closing, the solutions to the problem of prematurity 
must come through better prevention, and better prevention 
comes through strong public health prevention research. CDC 
addresses the problem of prematurity in the way that we face 
all of our epidemics--using all of our tools of health 
monitoring systems, integrated epidemiologic research, and 
social, behavioral, biomedical, and laboratory disciplines, and 
working with State and communities. Our prevention agenda 
includes three priorities.
    One is to research the causes and risk factors for 
prematurity. Second is investigating new ways to identify women 
at risk early in their pregnancy so we can intervene. And third 
is moving new research discoveries to public health practice, 
to save lives and prevent disabilities among America's babies.
    The challenges are many. The solutions are very complex. We 
are committed to building close partnerships with NIH and HRSA 
and the March of Dimes and our other public and private 
partners so that we can move forward in an effective and 
coordinated fashion.
    We know that we face many challenges, and these answers are 
not going to come easily. We are prepared to address these 
challenges and make a difference to the families of this 
Nation.
    Thank you again for this opportunity to be here today. I 
would be happy to answer any questions.
    [The prepared statement of Dr. Lackritz follows:]

                Prepared Statement of Eve Lackritz, M.D.

    Good morning Mr. Chairman and Members of the Subcommittee. I am Dr. 
Eve Lackritz, Chief of the Maternal and Infant Health Branch in the 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention. I am also a Commissioned 
Officer in the U.S. Public Health Service and a pediatrician. I am 
pleased to be here today to participate in discussions of the problem 
of preterm birth, which is one of the most devastating health issues 
facing women, children, and families in America today. I would like to 
take this opportunity to briefly outline the burden of disease in the 
Nation due to preterm birth and summarize current prevention and 
research activities and challenges. I will close by defining priority 
areas where CDC, in partnership with other governmental and 
nongovernmental agencies, need an expanded, comprehensive prevention 
research agenda, and an action plan for the prevention of preterm 
birth.

                               BACKGROUND

    In terms of the health of women and infants, preterm birth is a 
public health priority. Preterm labor is the leading cause of 
hospitalization among pregnant women. Preterm delivery is the second 
leading cause of death among infants, second only to deaths from severe 
birth defects. The crisis is particularly acute among African 
Americans. Complications from preterm births are the leading cause of 
death for African American infants today. This national epidemic of 
prematurity affects 12 percent of all births in the United States and 
17 percent of births among African Americans.
    We have very few health threats of this magnitude, and this health 
threat goes well beyond the burden of infant mortality. Preterm 
delivery is the leading cause of developmental disability in children, 
including cerebral palsy and mental retardation, and is an important 
cause of blindness and chronic lung problems. Infants who are born 
premature are more than two times more likely to have a birth defect 
than infants who are born at term. Premature infant births extract a 
huge financial toll on our healthcare resources. Hospital care of 
preterm infants costs over $13 billion each year. This is just for 
hospital care at their birth. Additional costs include hospitalization 
of mothers and continued care of children, including costs for repeat 
hospitalizations, medical visits, rehabilitation, and special services 
for children with special needs. But the toll of preterm delivery is 
not just financial. It tears at the fabric of our families and our 
communities, and takes an enormous emotional toll on mothers and 
fathers. Taken together, it is clear that preterm delivery is a public 
health priority.
    As a pediatrician, like tens of thousands of my colleagues across 
the country, I spent years working in the hospital wards struggling to 
combat the problem of prematurity, fighting to keep babies alive who 
were unable to survive on their own. All too often, I had to inform 
parents that their premature son had brain damage, or that their tiny 
daughter had debilitating handicaps, or that their newborn child would 
not be able to survive--all because they were born too early. Medical 
care has become more sophisticated over the years resulting in improved 
survival of preterm infants. But we are still left with unacceptably 
high rates of death and disability. It is clear that the solution to 
the problem of preterm delivery must come through better prevention. 
And better prevention can occur only through research to understand the 
reasons why too many women deliver too many infants too early.

                    CURRENT RESEARCH AND CHALLENGES

    CDC, as the Nation's prevention agency, addresses the problem of 
preterm delivery through research and programs, focusing on both the 
social and biomedical factors that affect preterm risk. CDC formulates 
a prevention response by identifying populations at risk, assisting in 
implementation of prevention programs, and monitoring progress of 
prevention efforts. CDC's work is achieved through three basic 
mechanisms: public health surveillance, support for State and community 
based programs, and epidemiologic and laboratory research.
Surveillance
    Surveillance is the core of CDC's work, the way in which we monitor 
how many infants are born premature, determine if trends are getting 
better or worse, define risk factors, and target prevention programs. 
Surveillance is our early warning system. It tells us if there is a new 
emerging health threat and if our programs are effective. There are two 
key surveillance systems that are used for preterm birth.
    The first major surveillance system focuses on the collection of 
vital records such as birth and death certificates. For preterm birth, 
this is the backbone of health surveillance, where risk factors are 
evaluated such as the mother's education, tobacco use, race, and the 
infant's birthweight. Vital records allow epidemiologists to follow 
trends, risk factors, and identify areas with high rates of preterm 
births. Although this system provides useful information, it is also a 
system facing some critical technology challenges. In this computer 
age, our data systems are antiquated. More flexible, timely, and 
responsive surveillance systems are needed to get vital information 
more quickly and effectively to decision-makers. It is an important 
time to move to a new, electronic vital records system, whereby risk 
factors for preterm birth and low birthweight can be measured and 
reported with greater speed and precision. CDC is working with partners 
in States and other Federal agencies to develop the nationwide 
standards and practices needed to implement this system, and the 
President has requested funding to support this effort in his fiscal 
year 2005 budget request.
    CDC's second key surveillance system on maternal and infant health 
is called PRAMS--the Pregnancy Risk Assessment Monitoring System. PRAMS 
is an ongoing, state-specific, population-based surveillance system 
designed to identify and monitor selected maternal behaviors and 
experiences before, during, and after pregnancy. Through this system, 
we have been able to better understand issues such as prenatal care, 
folic acid to prevent birth defects, obesity, stressful life events, 
and physical abuse. PRAMS provides vital information to program 
managers and decision-makers in 31 States and New York City, supporting 
the development of important policies and programs in maternal and 
infant health. Examples of policies and programs informed by PRAMS data 
include:
     PRAMS data on statewide breast-feeding initiation and 
duration prompted staff at the Maine Medical Center to examine breast-
feeding practices at their hospital. The study results, along with 
state-level data from PRAMS, were used to improve breast-feeding 
education and support in the Neonatal Intensive Care Unit.
     In New Mexico and North Carolina, PRAMS data were used to 
demonstrate the benefit of Medicaid coverage on early initiation of 
prenatal care.
     In Florida, North Carolina, Colorado, and Maine, PRAMS 
data are used to monitor knowledge about the benefits of folic acid and 
provide information to healthcare providers and community leaders for 
improving knowledge and use of folic acid.
    While PRAMS only covers 31 States, other States recognize the 
utility of PRAMS and are requesting assistance and participation. CDC 
is working to include as many States in this surveillance system as 
possible. States are asking CDC to help them analyze and use data for 
health policy and programs related to preterm delivery and infant 
mortality.
    In addition to these two key surveillance systems, CDC also uses 
more focused surveillance efforts to address specific health issues. As 
required under Public Law 102-493, CDC collects and analyzes data from 
all clinics that use infertility treatment termed Assisted Reproductive 
Technology (ART). CDC and other partners have used this system to 
evaluate the impact of ART on preterm birth and low birthweight, but 
there is still much to be learned in this area. Linking the ART 
surveillance data with State birth and death files provides a 
population-based database to examine maternal and infant health 
outcomes associated with this rapidly advancing technology. This 
activity was first initiated in 2001 when CDC developed a collaborative 
project with the Massachusetts Department of Public Health. Although 
recent research has indicated that ART is not driving the epidemic of 
preterm delivery in the U.S., it is important to continue to monitor 
its impact on preterm delivery.

Public Health Capacity
    CDC provides assistance to States and communities to collect and 
analyze data for development of maternal-infant policy and programs 
responsive to local, tribal, and State-specific needs. Fifteen CDC 
scientists are assigned to State health departments and one to an 
Indian Health Service epidemiology center. These assignees have 
assisted State public health agencies with the spectrum of maternal and 
infant health issues including prematurity. For example, in Michigan, 
the assignee helped to identify the largest racial infant health 
disparity in the Nation. This finding led to the formation of eight 
community initiatives targeting high risk communities, legislative 
mandating of a State infant mortality summit, developing a State policy 
white paper on prevention, and implementing new initiatives at a time 
of budget crisis. In Mississippi, the assignee evaluated the health 
outcomes of the State's system of perinatal care. With a national goal 
of 90 percent, only 40 percent of very premature babies are born in 
Mississippi's perinatal centers. (The mortality rate of babies born 
outside the centers is 50 percent higher than those born in perinatal 
centers.) These findings have led to much discussion statewide and the 
development of a legislative plan to address these shortcomings in the 
State.
    In partnership with the Health Resources and Services 
Administration (HRSA), the March of Dimes, local coalitions, and health 
departments, CDC epidemiologists worked with CityMatCH (a national 
organization of city and county health departments and maternal-child 
health program leaders) to develop Perinatal Periods of Risk (PPOR), a 
new approach to investigate a community's infant mortality problem. 
This simple method enables communities to quickly identify the problems 
so that they can move to action with prevention strategies. The uses of 
PPOR have been advanced through collaborative work in 12 cities across 
the country. PROR examines a community's fetal and infant mortality 
problems by mobilizing communities to address four primary prevention 
areas: maternal health and prematurity, maternal care, newborn care, 
and infant health. Prematurity was identified as the leading issue 
driving their infant mortality problem.
    CDC works with a number of community-based organizations such as 
Healthy African American Families in Los Angeles and through CDC's 
Racial and Ethnic Approaches to Community Health (REACH) programs in 
Michigan and California. CDC provides technical assistance and helps 
build networks of local organizations, public health workers, and 
health care providers in communities with high preterm delivery rates 
and ethnic minority populations. These networks begin to help increase 
awareness about preterm delivery in the community and promote healthy 
pregnancies.
    Despite the complexities of preventing preterm delivery, there are 
ways to build public health capacity. Tobacco use, for example, remains 
a major preventable cause of low birth weight. CDC has responded by 
working with State health departments to assist with smoking cessation 
programs during pregnancy.

Epidemiologic Research
    For more than 20 years, CDC has conducted research to understand 
the racial disparities in preterm delivery. Research has identified 
that stressful social factors, such as poverty, poor housing, and 
crime, exacerbate a woman's risk of preterm delivery. Bacterial 
vaginosis is also higher among African American women. CDC has 
conducted research evaluating interactions between adverse pregnancy 
outcomes and social factors, race, infectious processes and behaviors. 
For example, vaginal douching has been shown to be associated with low 
infant birthweight and bacterial vaginosis. More work is needed to 
elucidate the effects of these factors on preterm birth.
    In addition, we must remain vigilant to new and emerging threats to 
preterm delivery. The CDC and Indian Health Service recently learned 
about the use of a chewing tobacco product called Iq'mik, which is used 
widely among Alaska natives in the Yukon Delta region. Iq'mik is 
prepared by mixing chewing tobacco with the ash of a punk fungus, 
resulting in free-basing of nicotine and high blood nicotine levels. 
Analysis of PRAMS surveillance data found that well over 60 percent of 
women in the Yukon region were using this product during pregnancy. CDC 
responded by initiating a field investigation to assess pregnancy risk 
and assist with a prevention response.

             AN AGENDA FOR PREVENTION RESEARCH AND PROGRAM

    There have been promising new discoveries in the field of preterm 
delivery, but many unanswered issues remain. CDC recognizes that a 
comprehensive prevention research agenda is needed to better understand 
the multiple and complex causes of prematurity, address racial and 
ethnic disparities, and develop and implement effective strategies. 
Preterm delivery is one of the many challenging epidemics that CDC must 
address. We need to attack the problem of prematurity in the way that 
we face all other epidemics.
    Action steps to address preterm birth include:
     researching the causes and risk factors for preterm 
delivery;
     identifying women at risk early in their pregnancy;
     moving new research discoveries to public health 
prevention;
     expanding community-based programs on prematurity.

 1. Identifying Causes and Risk Factors for Preterm Delivery

    A complex array of factors interferes with healthy pregnancy 
outcomes and racial disparities. We know now that low grade infections, 
sometimes silent infections such as vaginal infections or periodontal 
gum disease, are associated with risk of preterm birth; however, a 
decade of research by NIH and their partners suggests that treatment of 
infections may not be effective in preventing preterm delivery. Perhaps 
the inflammatory response to infection, and not the infection itself, 
is responsible for preterm labor and delivery. We know that tobacco and 
psychological stress from living in poor neighborhoods create the same 
damaging chemicals in the body as infection. These same damaging 
inflammatory factors have been identified as mediators of 
cardiovascular disease, and are increased by the same factors such as 
periodontal gum disease, smoking, and stress. Damaging by-products of 
inflammation that spread throughout the body may result in increased 
risk of premature birth, as they have with cardiovascular disease. Our 
research agenda includes examining the role of inflammation on preterm 
delivery and opportunities for intervention.

 2. Early Detection and Screening

    Biological markers associated with preterm delivery, such as 
markers for inflammation, are often present very early in pregnancy, 
weeks to months before a preterm birth; however, these laboratory 
markers have not been thoroughly researched or applied to clinical 
practice. Our research agenda includes determining if there are ways to 
identify women at risk early in their pregnancy, so that they may be 
referred to tertiary care medical systems or provided with 
interventions to reduce their risk. A prospective study evaluating the 
causes of preterm delivery and early detection of women at risk would 
inform the research greatly.

 3. Moving Research to Prevention

    NIH recently completed an exciting new study that found that weekly 
injections of 17-alpha hydroxyprogesterone reduced the risk of preterm 
delivery among women who had had a prior preterm infant. But many 
questions remain regarding how best to move this new research discovery 
to widespread public health practice. This progesterone product is not 
commercially manufactured and it is unknown if women in high risk 
populations will accept painful weekly injections or what other risk 
groups might benefit from this intervention.
    In collaboration with NIH and other partners, a comprehensive 
research agenda is needed to evaluate drug availability, patient 
acceptability and adherence, and evaluate alternative routes of 
delivery such as a patch or suppository. Additional research is also 
needed to identify if other risk groups would benefit from progesterone 
therapy and evaluate how clinical practice has changed following these 
recent scientific findings. CDC can help address some of the 
operational challenges in moving research results to widespread public 
health practice.

 4. Expansion of Community-Based Programs

    CDC has made strides in working with communities to reduce racial 
and ethnic disparities in preterm delivery and infant mortality. 
Community-based programs serve to increase awareness about preterm 
birth, promote early initiation and continuity of prenatal care, and 
promote pregnancy health at the community level.

                               CONCLUSION

    Prevention of preterm birth is an important public health priority. 
Reducing preterm delivery poses many challenges, and the solutions will 
not come easily. A comprehensive research agenda would begin to 
identify the multiple and complex causes of preterm delivery and 
develop effective interventions. Together we can make a difference for 
the infants and families of this Nation.
    Thank you for the opportunity to speak to you about preterm birth. 
I would be happy to answer your questions.

    Senator Alexander. Thank you, Dr. Lackritz, and thanks to 
all three of you for laying a very strong base about what we 
know and what we do not know today about this mystery of why so 
many babies come sooner than they should and what the effects 
of it are on them and on our country.
    I will ask a few questions before we go on to the second 
panel. Before Senator Bond left, he asked if I would ask a 
question, and it is something, Dr. Van Dyck and Dr. Lackritz, 
that you both talked about--perhaps you did, too, Dr. 
Alexander. You talked about community health centers and the 
role of community health centers in the research and in moving 
what we know out to where it does some good.
    Is there more that any of the three of you could say about 
the role of community health centers and what the priorities 
should be for community health centers over the next few years 
as we think about how to prevent prematurity?
    Dr. Van Dyck. Community health centers are a HRSA-run 
program, so perhaps I will start.
    Community health centers form an important backbone in the 
health care delivery system of the Nation, and many, many poor 
pregnant women come to health centers for their care. The 
community health centers form an important part in inner cities 
as well as in rural areas of the overall delivery of health 
care.
    As part of the President's initiative, there is an 
expansion of the community health centers over the next several 
years, and I think an important expansion to try to improve 
access to care.
    Specifically, there is a new pilot collaborative around 
perinatal care which I described briefly, to try to get five or 
six or eight or ten people together to determine what the best 
practices might be to deliver the best perinatal care and help 
prevent preterm birth and prematurity and infant death. You 
then implement those practices in a small number of centers 
that have good data, so you can follow and track whether there 
has been improvement. If there is improvement, which often 
happens, that model can be replicated in other centers.
    This perinatal collaborative is beginning as we speak, and 
will be begun in up to six centers by the end of this year.
    So I think community health centers play an important part 
in the overall structure and delivery of this kind of care.
    The second piece is they probably form a wonderful 
opportunity to translate evidence-based research into practice, 
and I think that is one of the aims of our Low Birth Weight 
Committee, to identify those evidence-based practices which can 
work and try to find vehicles for the delivery of those 
practices in addition to the private sector--Healthy Start 
sites, community health center.
    So I think that as this Low Birth Weight Committee matures, 
and the findings come out, this will be an important piece of 
strengthening the delivery of care in community health centers.
    Senator Alexander. Thank you.
    Dr. Lackritz?
    Dr. Lackritz. I think there are two ways of thinking about 
community care. One is from the provider perspective, that 
people have access, and providers know what to do. The second 
is patient-centered. There are three direct areas in this. The 
patients need to have knowledge; they need to have the right 
attitude and an understanding; and finally, we know that 
knowledge by itself does not change behavior, so there are a 
number of things that we need to focus on terms of promoting 
community awareness, understanding what can motivate women and 
what can promote healthy behaviors. There are a number of 
things related to preterm delivery in this area.
    I think our experience is that we have learned to listen to 
communities. I do not think people, certainly women, take a 
direction that is just told to them. We need to understand how 
best to communicate how to get our message across and how to 
motivate the population, from any number of things from 
accessing prenatal care to douching to getting treatment for 
infections.
    Senator Alexander. Which is the bigger problem--finding and 
reaching out, communicating with pregnant mothers, or knowing 
what to tell them when you find them?
    Dr. Lackritz. And having the research tools that will guide 
all three of those areas.
    Senator Alexander. What has come out here is that there is 
a great deal of unknown here--that is the point of the hearing, 
that we do not know why there is a great deal of prematurity. 
Dr. Alexander, you especially brought that out, and that many 
of the things that we thought work--you mentioned bed rest--I 
have two friends right now who are using bed rest in their 
pregnancies--but you said that in your research, it is not 
useful.
    Dr. Alexander. Yes, that is correct. One of the useful 
things about research is that it often shows that some of the 
things we have believed for many years are actually not true. 
So even a negative study has great value. It stops a practice 
that does not work. It ends some of the costs that are 
associated with that and some of the time and effort that go 
into that. And it also shows you that you have got to find some 
better way to treat this other than what you are doing, because 
what you are doing does not work.
    Senator Alexander. Based on what we know today--and we are 
delighted that Senator Dodd is here, and I will turn next to 
him for his remarks and any questions he might have before we 
go to the second panel--but if a pregnant mom were watching 
today, or later reading your statement, what are the two or 
three things that we do know that one ought to do to discourage 
prematurity? What actions can an individual take, based on good 
research and on science that we know today?
    Dr. Alexander. Let me start with that if I may. First of 
all, plan pregnancy. Fifty-four percent of the pregnancies in 
the United States, with all the information we have about what 
causes pregnancy--we know that pretty well, and we also have 
pretty good information on how to prevent pregnancy if we do 
not want to have it--in spite of all that, we still have 54 
percent of pregnancies in the United States unintended, 
unplanned. And there is very clear information that those 
pregnancies are at greater risk for prematurity, low birth 
weight, than the intended, planned pregnancy.
    So planning pregnancy is a start. Also, a woman before she 
gets pregnant getting her health in as good a status as it can 
be before she gets pregnant, including starting to take folic 
acid before she is pregnant; also, a preconception examination 
and evaluation by a physician for general health status is also 
useful; stopping smoking if she is a smoker--of all the things 
we know that will reduce the prevalence of low birth weight, 
stopping smoking is number one on the list; it is the most 
effective thing we can do. But too many of our women are still 
smoking during pregnancy, and that is a significant contributor 
to low birth weight.
    Also, getting prenatal care right from the start, with 
regular examination and follow-up, allows you to have detected 
things like preeclampsia or preterm labor at an early stage 
when we can try to intervene with a variety of things, many of 
which we still do not know how to do. But for example, we now 
have progesterone available for a woman who has had a preterm 
delivery before. We do not know yet if that works for other 
conditions. One of the priorities we have for our Maternal-
Fetal Medicine Networks is to study progesterone for other 
conditions--twin and triplet pregnancies, for example, short 
cervical length, and women who have certain other conditions. 
We need to test this treatment and see if it will work for them 
as well.
    But that is my short list. The others may have other 
suggestions.
    Senator Alexander. Well, that is pretty good list--plan the 
pregnancy, folic acid, good health, take an exam, no smoking, 
prenatal health care--that means get a doctor before you have 
your baby, not after--and progesterone, maybe.
    Would you add to that, Dr. Van Dyck, Dr. Lackritz?
    Dr. Van Dyck. I would just like to say that there are still 
a lot of women who do not get prenatal care, do not have easy 
access to prenatal care, do not do the simple things related to 
prenatal because of poverty or lack of access to clinics.
    Senator Alexander. Do you have any idea what percent of 
women do not have access to a pediatrician or a medical 
facility before their babies are born?
    Dr. Van Dyck. Well, we know that up to 10 percent of women 
do not get prenatal care, and an even larger percentage do not 
get adequate prenatal care. So there are significant 
improvements that we can make even with what we know by 
providing better access to women and better education to women 
who do not access the good prenatal care that we have.
    Senator Alexander. Dr. Lackritz, would you like to add 
anything?
    Dr. Lackritz. I agree. I think it gets back to our original 
message, that there is a lot that we do not know, but at the 
same time, there is a lot that we know and need to do better 
with. I think the tobacco cessation example is perfect. We do 
support some States on that, but we really could do more, and 
States are asking us to do more.
    I think another good example is behaviors such as douching. 
It also demonstrates this interaction between biology and 
behavior. We know that bacterial vaginosis is associated with 
preterm delivery. We know that these vaginal infections are 
sometimes two to three times higher in African American women 
than in white women, and we know that African American women 
are more likely to douche during pregnancy.
    So it is a matter of understanding if there is a biological 
interaction between these behaviors and the infectious 
processes, and how can we best intervene, both on the 
behavioral aspects as well; how can we motivate women and 
educate women on the dangers of certain behaviors.
    Senator Alexander. Thank you.
    Senator Chris Dodd is a long-time member of this committee 
and a leader--depending on how the elections go, he is chairman 
of it sometimes--but in any event we work together on many 
issues and especially on this one, and we are partners and 
cosponsors of this legislation, announced it together and work 
on it together. I am delighted he is here.
    Senator Dodd, we have heard from these witnesses. Why don't 
we go to you for any statement you might have, and when you 
have finished, we will go to the second panel so we have a good 
chance to hear from them. But take whatever time you would 
like.
    Senator Dodd. Thank you very much, Mr. Chairman, and I 
thank our witnesses.
    I apologize for arriving late. I care so much about this 
hearing, and I cannot tell you how exciting it is to work with 
Lamar Alexander on these issues. It has been one of the real 
joys of my career in the Senate to have someone who is 
committed to these issues as much as Lamar is.
    The witnesses will appreciate this--I have a 2\1/2\-year-
old daughter, and I was with her this morning. I would normally 
come up with an excuse like there is a very important hearing, 
but I am going to be away for 3 or 4 days, and I did not want 
to go away without spending a little time with her this 
morning. So I apologize. I know we are not supposed to admit 
these things on CSPAN.
    Senator Alexander. I think your approval rating just went 
up.
    [Laughter.]
    Senator Dodd. I am a first-time father, and I suspect I am 
a lot better at this today than I might have been 25 or 30 
years ago. I am not sure I would have made the same decision 
this morning a number of years ago. So I apologize for that. 
But I am deeply grateful again to the chairman for being so 
involved and for caring so much about this, and the witnesses 
as well.
    Let me just make a couple of opening comments, and then I 
have some questions.
    I think Senator Alexander is asking a very good set of 
threshold questions that I think are important to try to get 
the magnitude of all of this.
    I was talking to my sister--I have an older sister who is a 
grandmother of 13, with five children--and not too long ago, we 
were talking about this issue of prematurity in infants and so 
forth, and she was describing that when her first child was 
born--my sister was a smoker--she and the doctor both took a 
break to have a cigarette during the delivery of her first 
child. That is ancient history, going back about 40 years, but 
nonetheless that is how cavalier people were about that.
    The single most important thing for people to do, as you 
point out, Dr. Alexander, is to stop smoking; if you had to 
pick one thing, that is the one thing that can make a 
difference.
    But I had thought about this as being sort of a normal 
issue until I became aware of the statistics. I think every one 
of us knows someone today who was a premature child, so I just 
assumed this was a normal thing that happens with some 
frequency but not any huge health concern until I began to look 
at the numbers and discovered that one out of every eight 
children born is premature, 480,000 in the country; about 1,300 
every day are born premature in this country. I have about 
4,000 in Connecticut.
    And looking at the numbers and where they are coming from 
and what is happening and what can be done--obviously, the 
legislation that we have introduced here, along with our 
colleagues in the House, by the way--it is one of those unique 
situations where we have a companion bill exactly in the House 
of Representatives.
    So I will just ask that a written statement be put in the 
record, if I can, rather than taking the time to read it now, 
and ask you some questions about this.
    First of all, is there a profile that is developing in 
terms of economics, age? One thing that occurred to me when you 
were talking about some of the things to avoid is to what 
extent as a young child--we now have a lot of teenagers and 
even preteens in some cases delivering--is there a higher 
incidence of prematurity with younger women? Historically, one 
argues that younger, healthier women are actually better able 
to carry to term, but is that sort of a myth that we have been 
living with?
    Economics is very important. I am glad the Senator asked 
that question. Is there a profile that has developed here so we 
can begin to see that there is a much higher rate of 
prematurity among mothers who come from lower economic 
circumstances? Obviously, there is data that would probably 
corroborate that, given access to health care and a variety of 
other things. I would be curious if we could begin to develop 
some sort of profile of that mother and what she is living 
with; it would be helpful.
    And then, I was curious because I noticed that the 
traditional source of neonatal death for years was respiratory 
ailments, but that actually, respiratory ailments are on the 
decline--at least, the data points to that. So what are the new 
factors that are contributing to this increase since 1958 in 
the 2002 data?
    I will ask the panel, whoever wants to respond.
    Dr. Lackritz. All of us could probably answer this.
    In terms of age, you get what we call a bimodal 
distribution--very young women are at increased risk of 
prematurity, and older women are at increased risk of 
prematurity.
    The thing we try to focus on in public health is--we do 
have a well-described profile of women--what are the 
preventable factors. In some of these, the mother had a preterm 
birth. Well, I cannot really intervene in that--although even 
those types of issues, we know that we need to get those women 
early, monitor them closely, and make sure they know that they 
need to deliver in a tertiary care facility.
    I think there are a number of important factors in terms of 
risk factors that we need to focus on. The main thing is race 
in America; that women who are African American have three 
times the rate of low birth weight than white women. Now, if 
you control for economics, yes, we also know that poor women 
are more likely to be at risk. We know that women who live in 
urban areas that have a high crime rate and crowding and who 
live in stressful urban settings are at increased risk for 
preterm delivery.
    Senator Dodd. How much of an increase? What are we talking 
about here, Doctor?
    Dr. Lackritz. I would say about twice as much--and we can 
see that that increase due to those environmental stresses is 
worse in African Americans. So if we look at poor white women 
living in stressful environments and poor black women, those 
African American women are suffering even more because of those 
social factors.
    The interesting thing about race, though, too, is if we 
look at foreign-born women, that foreign-born black women 
actually have lower preterm delivery rates than black women who 
are born in the United States. So it is not purely generic, and 
it is not purely cultural, and it is not purely economic. It is 
clearly a combination of a number of factors that are 
influencing it. But if I had to say what is one of the most 
important things we need to focus on, it is this racial 
disparities issue that is driving a lot of the infant mortality 
problems we have in America today. It is a very big proportion.
    Senator Dodd. Dr. Van Dyck, do you want to comment?
    Dr. Van Dyck. I do not think so. I think that is the 
important profile.
    Senator Dodd. Dr. Alexander?
    Dr. Alexander. Let me just say a couple things about the 
rising rate of prematurity that we have seen lately and a 
couple of the factors that may be contributing to that. It is 
not exactly a profile of the risk, but there are some things 
that we do know about risk where the population is changing in 
a way that is increasing the likelihood of premature delivery.
    One of those is the age at which women are having children. 
Older women have a higher likelihood of premature birth, and we 
are seeing a shift at ages at which women are having children. 
In the fifties, sixties, and seventies, the percentage of women 
who were older was declining, and prematurity rates declined at 
that time. In the last 2 decades, that percentage has 
increased, and with it, there has been the increase in 
prematurity. That accounts for a part of it.
    Also, it is accounted for in part by the increase in 
obesity--obese women are more likely to have a premature birth. 
And there is also the fact that we tend to intervene more 
aggressively obstetrically when a pregnancy gets into trouble, 
when a fetus gets into trouble, and deliver it at an early age 
because we can save those smaller babies more effectively than 
we used to be able to.
    Senator Dodd. You triggered that--I meant to ask that in my 
preliminary question. In terms of death rates of infants, how 
has that changed? If you compare death rates of newborns, say, 
20 years ago to death rates today--obviously, in a lot of these 
cases, given technology and the advancement of medicine, we can 
save a lot of these children--but not that many years ago. 
There is a question mark there.
    Dr. Lackritz. And that links to your question about lung 
disease, too.
    Senator Dodd. Dr. Alexander, I am sorry. I apologize.
    Dr. Alexander. Let me address that. One way of looking at 
it is the average weight at which half the babies are born 
survive. Twenty years ago, 30 years ago, that was around 1,500 
grams, or a little less than 3 pounds. Today it is around 700 
grams--half the babies survive.
    If you look at deaths from respiratory distress syndrome in 
premature babies, those have dropped dramatically because of 
the availability of surfactant, because we treat premature 
labor with steroids to try to mature the lungs, etc.
    A way of looking at this that is quite dramatic is to look 
at what has happened with respiratory distress syndrome deaths. 
A case-in-point is John Kennedy, who was largely responsible 
for NICHD being established and advocating that with the 
Congress back when he was President. He had a premature son, 
Patrick, born in 1963. At his birth weight and gestational age, 
he developed respiratory distress syndrome. We had no idea what 
caused it, we had no effective treatment, and he died at 4 days 
of age because of no therapy. He had a 95 percent chance of 
dying then because we did not have effective treatments or 
knowledge of the cause.
    Since then, we have found the cause, we have developed 
effective treatments, and if Patrick Kennedy were born today at 
that same gestational age and birth weight, instead of having a 
95 percent chance of dying, he would have a 95 percent chance 
of surviving.
    That is a dramatic example of the improvements. But we are 
having more premature babies born, and that is what we have got 
to attack. That is the major problem we have. Our numbers are 
going up, not down.
    Senator Dodd. Dr. Lackritz, you mentioned research into 
environmental contaminants and their link to premature birth. I 
think you touched on this a little bit in answer to my first 
question, but I wonder if there is a further elucidation that 
you would like to make about environmental contaminants and 
their effects. You mentioned that these numbers are higher in 
urban settings, and you mentioned stress and violence, but I am 
also wondering whether, despite all of our efforts in clean air 
and clean water--in Washington, DC, lead in the water that we 
have now discovered--to what extent are these kinds of 
environmental contaminants possibly contributing to these 
increased rates?
    Dr. Lackritz. It has been a big question, and it is very 
hard to tease out, because getting hard data on that kind of 
thing, looking at was it lifetime exposure or was it early 
exposure, is it exposure during pregnancy--it is analytically a 
very complex question, but it is an obvious question that all 
of us are looking at now.
    Dr. Alexander. It is a question that is extremely 
important. The problem with the studies that have been done in 
the past is that the numbers have been too small, the follow-up 
has been too short, and we have only looked at one or two 
contaminants of the environment at a time.
    What we have now before us is the opportunity to do a much 
more definitive study on environmental influences on premature 
birth, on birth defects, on a number of other situations that 
affect children.
    You, as one of the prime sponsors of the Children's Health 
Act of 2000, included in that a directive to the NICHD to lead 
a consortium of Federal agencies to develop and plan and 
conduct a National Children's Study, which is a longitudinal 
study of environmental influences on children's health and 
development. We are currently in the process of planning that 
study. The very first information that we will have from that 
study will be information on prematurity and birth defects, 
because the outcomes we will have in that will come first.
    That study plans to enroll a cohort of about 100,000 women 
recruited during pregnancy, with extensive information gathered 
from them on environmental exposure history, also of the 
father, also DNA from both parents as well as from the infant, 
information on the course of pregnancy, as well as 
environmental sampling from the home, the community, whatever 
the mother is exposed to, as well as blood levels of a wide 
variety of environmental contaminants.
    All of these can be looked at at once, rather than just one 
or two. We can look at 100 and look at correlations between 
outcomes and the environmental exposures and the genetic makeup 
of mother and father and baby, and try for the first time, 
because of the large numbers that we will have in this study, 
to really put together the picture of what environmental 
influences are affecting pregnancy outcomes in terms of 
prematurity, low birth weight, birth defects, and developmental 
status, because we plan to follow these kids to age 21.
    Senator Dodd. That fits in very, very neatly in the sense 
of what we are doing.
    Just a couple more quick questions. You mentioned SIDS, Dr. 
Alexander, Sudden Infant Death Syndrome. In fact, Don Imus the 
other day dedicated a week, or a significant portion of 1 week, 
of his show to not only raising money for this camp that he and 
his wife have, but also for SIDS, and I have been involved with 
it for a long time in my own State.
    Tell me what the connection is here. You mentioned it all 
through your testimony. What is the connection between that and 
prematurity?
    Dr. Alexander. A premature baby is much more likely to die 
of SIDS. It is two to three times more prevalent among preemies 
than it is among term babies. So that is definitely a risk 
factor for SIDS and one of the reasons why those babies need to 
be watched even more carefully and why it is even more 
important for those babies than anybody else to be placed on 
their backs to sleep rather than on their tummies.
    This is one of the real successes that we have had in 
reducing infant mortality in this country. The reason we made 
our goal of an infant mortality rate below 7 by the year 2000 
in Healthy People 2000 was the fact that we were able to cut 
SIDS as much as we did with the Back to Sleep Campaign.
    We have reduced Sudden Infant Death Syndrome from 1992 to 
2002 by more than 50 percent just by the public information 
campaign to get parents to put their babies to sleep on their 
backs instead of on their tummies.
    Senator Dodd. I said Dr. Alexander, but actually, Dr. Van 
Dyck, you are the one who mentioned SIDS all through your 
testimony, and I apologize. Nonetheless, do you agree with 
this?
    Dr. Van Dyck. Absolutely. We are both involved in the Back 
to Sleep Program--all of us are--and work side-by-side.
    Senator Dodd. The last question I have for you--and Dr. 
Lackritz, I will address it to you, but others can comment as 
well--you testified about the risks that children face later in 
life as a result of prematurity--blindness, cerebral palsy. Has 
any link been found with emotional problems? We read every day 
about the increased problems with attention deficit disorder 
and depression. We have held hearings here and talked about the 
increasing rates of suicide or attempted suicide among 
children.
    Are there any efforts or any studies ongoing to go beyond 
the physical ailments that one might associate with prematurity 
and to move into this growing problem of emotional disorders 
that we find your people suffering from?
    Dr. Lackritz. During that premature period, it is a very 
critical period of brain growth that can affect a number of 
sequelae. There are a couple of things that go on. There is a 
very fragile blood supply in the brain that is sort of at the 
inner part of the brain, and that often bleeds in premature 
infants. That vascular bed is just not stable enough for a baby 
to be born. That alone is probably related to a lot of later 
sequelae.
    The other point thing is, as you were saying, the link 
between lung and oxygenation and normal brain growth.
    In terms of specifics like attention deficit disorder, I am 
not sure about that, and I could find out, but I think that in 
general, we are getting much better abilities to assess 
children psychologically, and we will be able to get more data 
as we go along.
    Senator Dodd. In this life study that we are doing, is 
there any possibility beyond what you are looking at to improve 
the idea of looking at the emotional responses of children as 
they mature?
    Dr. Alexander. Yes. The legislation asked us to study 
environmental influences not just from the physical environment 
but also from the behavioral, social, cultural, community, and 
family environment, and on a wide variety of outcomes, again, 
not just physical but behavioral, intellectual, how kids do in 
school, how they learn, how they grow and develop. So all of 
those things will be incorporated.
    Senator Dodd. Thank you, and I apologize again, Mr. 
Chairman, and thank you immensely. I thank all three of you, 
and I may have some additional questions for you. I know that 
Senator Alexander has covered a lot of ground already, so I 
will end there, and if I think of some more things, I will send 
them along to you.
    But I am very excited--I had forgotten about this study 
that we authorized and thank you for reminding me. When are we 
likely to start getting some data?
    Dr. Alexander. The planning has been going on, actually, 
since around the time the legislation was passed. We have 
recruited staff to do the planning. We have conducted a number 
of pilot studies. At the present time, our plans call for 
actually starting to recruit the sample by the end of fiscal 
year 2000 if we get the funding to do it. The recruiting of the 
sample will take 3 to 4 years, and as I said, the first data we 
have will be pregnancy outcome, which will tell us a lot about 
prematurity.
    Senator Dodd. Great. Thanks.
    Thank you, Mr. Chairman.
    [Statement of Senator Dodd follows:]

                Statement of Senator Christopher J. Dodd

    Mr. Chairman, I would like to thank you for holding today's 
hearing on premature birth and low birthweight. I think when 
many of us hear about a baby being born early, we don't give 
much thought to what it means. After all, it is not all that 
uncommon--I'm sure that almost everyone in this room knows 
someone born prematurely. Thanks to modern medicine it is also 
not uncommon for a baby born early to end up healthy and happy.
    But this feeling that prematurity is somehow ``normal'' or 
to be expected masks a growing health crisis. As we will hear 
from our witnesses today, prematurity has real consequences in 
health and economic terms. That's why this hearing is so 
important. We need to bring light to this issue that affects 
some of the most vulnerable members of our society: newborn 
babies.
    As many of you may know, it was a little over 2\1/2\ years 
ago that my wife Jackie and I were blessed with a child of our 
own. As the ranking member (and in the past, chairman) of the 
Subcommittee on Children and Families, I have devoted much of 
my time and effort to improving the health of our Nation's 
children and infants.
    And yet despite my personal and professional experience, I 
was shocked to learn about the magnitude of the problem of 
prematurity. I always understood the pain and hardship that can 
afflict a family when a child is born too small or too soon. 
But what is so striking about prematurity is how many parents 
face these enormous emotional and financial burdens. Nearly 1 
out of every 8 babies in the United States is born 
prematurely--that's 1,300 babies each day, and over 470,000 
each year (including more than 4,000 in my home State of 
Connecticut).
    And despite all of the health care advances of the last 
decades, the problem of prematurity is not going away. 
According to recent data released by the National Center for 
Health Statistics, in 2002 the infant mortality rate actually 
increased for the first time since 1958. Much of this increase 
is attributable to infant death in the first month of life--of 
which prematurity is the leading cause. Since 1981, the 
premature birth rate has increased by 27 percent. This stands 
in stark contrast to some of the breathtaking medical 
discoveries of the past 2 decades. We can now treat and even 
cure many types of cancer, but we can't prevent babies from 
being born too soon.
    The consequences of prematurity are devastating. As I 
mentioned earlier, it is the leading cause of neonatal death--a 
tragedy that no family should have to face. For those infants 
that survive, a lifetime of severe health problems is not 
uncommon. Prematurity has been linked to such long-term health 
problems as cerebral palsy, mental retardation, chronic lung 
disease, and vision and hearing loss. Premature babies have the 
deck stacked against them from the moment they are born.
    As we will hear today from one of our witnesses, Kelly 
Bolton Jordan from Senator Alexander's home State of Tenessee, 
even in the fortunate cases where there are no life-long health 
consequences, the experience of a premature birth takes an 
enormous emotional toll on a family.
    Prematurity also carries a significant economic cost. 
According to a recent study conducted by the March of Dimes 
(represented here today by Dr. Jennifer Howse, the 
organization's President), hospitalizations due to prematurity 
cost a total of $12 billion during the year 2000--accounting 
for nearly half of all hospital charges for infants in this 
country.
    Given the emotional and economic toll that prematurity 
takes on this country, we know remarkably little about why it 
happens, and how it can be prevented. As we will hear from our 
witnesses, some of the risk factors associated with preterm 
birth are known, including advanced age of the mother, smoking, 
and certain chronic diseases. But nearly 50 percent of all 
premature births have no known cause. And because we know so 
little about the causes of prematurity, we also do not know how 
to prevent it.
    For such a large (and growing) problem, it is astounding 
how little we know. It is critical that we make a national 
commitment to solving this puzzle. We must do everything we can 
to expand research--both public and private--into the root 
causes of prematurity.
    Senator Alexander and I [along with Representatives Anna 
Eshoo and Fred Upton in the House] have introduced the 
Prematurity Research Expansion and Education for Mothers Who 
Deliver Infants Early--or PREEMIE--Act for precisely this 
reason. Our bill would coordinate and expand research related 
to prematurity at the Federal level. It would also educate 
health care providers and the general public about the risks of 
prematurity, and measures that can be taken before and during 
pregnancy to prevent it. Pregnant mothers need to know the 
warning signs and symptoms of premature labor--and they need to 
know what to do if they begin to notice those signs.
    Finally, because we will never eliminate prematurity 
completely, our legislation would provide support services to 
families impacted by a premature birth. As we're investigating 
the causes of prematurity and increasing awareness in expectant 
parents, we need to reach out to the mothers and fathers across 
our country whose children are born too soon. We need to give 
them emotional support during the difficult days, weeks, and 
months that often follow a premature birth. We need to make 
sure that the doctors, nurses, and other hospital staff who 
care for premature babies are sensitive to the needs of their 
parents, their brothers, and their sisters. And we need to make 
sure that when the time finally comes to bring a premature baby 
home, parents have all the information they need to make that 
transition.
    It is my hope that this legislation will complement and 
support some of the efforts going on in the private sector--
such as the March of Dimes ambitious campaign to increase 
public awareness and reduce the rate of preterm birth. I am 
proud to say that one of the individuals leading our Nation's 
efforts to better understand prematurity is from my home State 
of Connecticut. We will hear from Dr. Charles Lockwood of the 
Yale University School of Medicine and Yale/New Haven Hospital 
in our second panel of witnesses. He and our other witnesses 
will certainly have more to say about the efforts to combat 
prematurity in hospitals and research institutions throughout 
the country, and the importance of investing in this type of 
research.
    Once again Mr. Chairman, I thank you for turning our 
attention to this important matter. I look forward to hearing 
from our witnesses.
    Senator Alexander. Thank you, Senator Dodd.
    An increasing number of medical students are taking a year 
in public policy at some time in their preparation, and I think 
the careers of the three of you are good examples of why that 
is a good idea. This has been very, very helpful, and I thank 
you for coming this morning.
    Dr. Alexander. Thank you.
    Dr. Van Dyck. Thank you very much.
    Dr. Lackritz. Thank you.
    Senator Alexander. I would like to invite the second panel 
to come forward, please.
    Let me introduce the three witnesses. Dr. Jennifer Howse is 
president of the March of Dimes and has a distinguished 
career--a doctorate in child language development from Florida 
State; she is a member of Secretary Thompson's Advisory 
Committee on Genetic Diseases in Newborns; she is an advisor to 
the Secretary's National Commission on Infant Mortality.
    She has been president of the March of Dimes since 1990, 
and under her leadership, the March of Dimes has significantly 
expanded its mission. She will tell us more today about the 
March of Dimes' latest campaign to reduce premature births.
    Dr. Charles Lockwood is the Anita O'Keefe Young Professor 
and chairman of the Department of Obstetrics, Gynecology and 
Reproductive Sciences at Yale University School of Medicine. He 
will talk to us about the status of research on prematurity. He 
has a background at Brown University, at the University of 
Pennsylvania School of Medicine, and at Yale University.
    And Ms. Kelly Jordan delivered a baby girl 3\1/2\-months 
early. She is from Memphis. Her daughter Whitney's pictures are 
with us today; she is a beautiful little girl.
    Ms. Jordan is also vice president and senior financial 
advisor for Merrill Lynch.
    We welcome all three of you. Why don't we start with you, 
Dr. Howse, then Dr. Lockwood, and then Ms. Jordan. And we want 
you to be able to say everything you would like to say. If you 
could summarize what you have to say in 5 to 7 minutes, we will 
have more time for questions, but please feel free to tell us 
what you would like us to hear.

  STATEMENTS OF JENNIFER L. HOWSE, PRESIDENT, MARCH OF DIMES; 
CHARLES J. LOCKWOOD, M.D., CHAIRMAN, DEPARTMENT OF OBSTETRICS, 
 GYNECOLOGY, AND REPRODUCTIVE SCIENCES, YALE UNIVERSITY SCHOOL 
       OF MEDICINE; AND KELLY BOLTON JORDAN, MEMPHIS, TN

    Ms. Howse. Thank you very much, Chairman Alexander and 
Senator Dodd.
    We are very grateful to have your support around this 
important issue, and we are very grateful to have time for this 
hearing so that you all can have an opportunity to learn first-
hand from expert panels and concerned individuals about this 
growing problem of prematurity.
    I think what you have heard this morning from the first 
panel is that this is a serious problem with serious 
consequences, a problem that is growing, a problem that is 
quite costly and relatively common nowadays, and that we need 
to find a way to prevent prematurity. We need research that can 
give us additional tools that can intervene and can stop 
prematurity, and we need to do a better job of applying those 
few interventions that we already have available, such as 
smoking cessation and the progesterone therapy. Above all, we 
need to join in partnership--the able Federal representatives 
that you have heard from this morning, the volunteer sector 
which we represent with March of Dimes, and the research 
community and the academic community. We need to join together. 
We have joined together. We are a quite determined band of 
committed organizations and individuals to provide sustained 
support so we can solve this problem for our country together.
    I think that what I will do very quickly is just remind you 
all and thank you on behalf of the 3 million volunteers of the 
March of Dimes, the 1,400 staff of our organization. Senate 
bill S. 1726 is extraordinarily important and meaningful to our 
volunteers.
    We are an organization that is now 66 years old. We are 
devoted to various aspects of improving children's health. We 
kind of see our trajectory, if you will, as from polio to 
prematurity, with a lot of stops in between around important 
children's health issues that we believe we have been, as March 
of Dimes, important in solving these problems.
    In 2003, we launched this National Prematurity Campaign. We 
based it on the best data and scientific evidence that we could 
compile. We know, and you have heard this morning, that this is 
a growing problem, a major contributor to infant mortality, and 
certainly it is the number one cause of mortality among black 
infants in this country, and although these infants account for 
about 12 percent of the births, nevertheless there is a 
disproportionate share of infant death in the African American 
community.
    Our campaign, at least its first phase, is 5 years. We will 
devote $75 million of March of Dimes money to this campaign. 
This will be raised by our volunteers across the country. We 
are pleased to be joined in partnership with the American 
College of Obstetricians and Gynecologists, the American 
Academy of Pediatrics, the Association of Women's Health, 
Obstetric and Neonatal Nurses. These organizations form our 
steering committee and guide the Campaign. We have so far 35 
other national organizations who have joined and have become 
part of the National Prematurity Campaign alliance.
    Our goal in this Campaign is to reduce the rate of 
prematurity by at least 15 percent by 2007. I think that is a 
formidable goal. When you consider the fact that prematurity 
rates have been rising for the last 2 decades, I know you can 
appreciate that both to stop the rise as well as to achieve a 
decrease in rates of prematurity is a tall order.
    I believe the Campaign is well-planned and well-ordered. We 
will invest our own March of Dimes dollars in more research, 
and we will also seek to have additional Federal support for 
research. You heard very ably, I think, from Dr. Alexander 
about that. We seek to educate women as to the signs and 
symptoms of preterm labor so they can get connected with their 
health providers at an early stage when the problem is 
manifesting, and we will also be providing support for those 
480,000 families every year who experience a baby born 
prematurely. You will be hearing more about that first-hand 
from Kelly Jordan.
    We are also concerned about lack of access to health 
coverage for women, particularly in the early stages of 
thinking about starting a family and in early stages of 
pregnancy, so we will devote resources in the Campaign to that 
as well.
    I mentioned prematurity as costly. I will summarize this 
very quickly. The cost of the average hospital stay for a 
healthy newborn without complications is $1,300. For a baby 
born premature with a principal diagnosis of prematurity, it is 
$75,000 for that hospital stay. So you can begin to appreciate 
the dramatic cost implications. For all infants born in the 
year 2001, their hospital stays amounted to $29.3 billion, and 
about half of that amount, $13.6 billion, is the hospital 
charges ascribed to infants with a diagnosis of prematurity. So 
half the hospital charges for the labor and delivery are 
associated with 12 percent of the births. Again, you begin to 
really appreciate the disproportionate costs associated with 
prematurity, and of course, the bill is paid by employers and 
by individuals, but most particularly by employers, private 
health plans, business, and the Medicaid program.
    There are other costs as well. The consequences of 
prematurity are quite severe in terms of health problems--you 
have heard about that--cerebral palsy, developmental delay, 
blindness. There are data--for example, in the Journal of the 
American Medical Association, there is a very well-developed 
article published in 2002 that demonstrates the connection and 
the greater risk for babies born premature both for lower 
cognitive test scores as they go to school, as well as for 
behavioral problems such as suicide and emotional problems, 
particularly as they begin to reach their teen years. So this 
is a problem that does not stop when the baby graduates from 
neonatal intensive care; for many of the infants, it continues 
to be a matter of lifelong health consequences.
    This legislation, S. 1726, is extraordinarily important to 
us. While there have been very important steps taken within the 
Federal agencies to begin to come together around the problem 
of prematurity and the associated condition, low birth weight, 
nevertheless this bill would provide a framework, would provide 
specific guidance, and frankly, it would codify the interest of 
the Congress in this problem of prematurity and would help us 
work together over a sustained period of time.
    The bill would expand, intensify and coordinate research 
related to prematurity. You will be hearing more about that. It 
also contains some important provisions that attach to the 
children's health study, and you have heard that elaborated. In 
particular, there are three activities that I would like to 
draw to your attention.
    First, the bill would establish a Surgeon General's 
Conference on Prematurity and Low Birth Weight. This would be 
very important and would really give an opportunity for many of 
us to come together, share what we know, and also outline what 
we need to learn in order to tackle the problem. It would 
develop a consensus research plan for HHS on prematurity and 
low birth weight, again, gathering the resources already in 
place to augment the effort. It would also allow for regular 
reporting to the HHS Secretary and to the appropriate 
committees of the Congress on these activities.
    So we are very, very pleased that you all have taken 
interest in this problem and that this bill has been 
constructed. We hope that it will receive approval in the very, 
very near future.
    Again, on behalf of all of our volunteers and our staff and 
the organizations that we work with in partnership, thank you 
very, very much for your interest in the problem.
    Senator Alexander. Thank you, Dr. Howse.
    [The prepared statement of Dr. Howse follows:]

             Prepared Statement of Jennifer L. Howse, Ph.D.

    Mr. Chairman, and Members of the Subcommitee, I am pleased to be 
here today to discuss with you the growing public health crisis of 
premature birth. On behalf of the 3 million volunteers and 1,400 staff 
members of the March of Dimes, I want to thank Chairman Alexander and 
Ranking Member Dodd for their interest and work on reducing the rates 
of preterm birth and particularly for introducing S. 1726, the PREEMIE 
Act.
    As you know, the March of Dimes is a national voluntary health 
agency founded in 1938 by President Franklin D. Roosevelt to prevent 
polio. He took an unprecedented action believing in the power of the 
volunteer. It took 17 years, breakthroughs in research, and hundreds of 
volunteers before the Salk vaccine was developed, and the victory 
against a dread disease secured. Today, the Foundation works to improve 
the health of mothers, infants and children by preventing birth defects 
and infant mortality through research, community services, education, 
and advocacy. The March of Dimes is a unique partnership of scientists, 
clinicians, parents, members of the business community, and other 
volunteers affiliated with 54 chapters in every State, the District of 
Columbia and Puerto Rico.
    Once the Salk vaccine was declared safe and effective, the March of 
Dimes turned its attention to preventing birth defects, supporting 
researchers who developed prenatal diagnostic tests and organizing and 
supporting a nationwide network of genetic service centers and regional 
neonatal intensive care units. Scientists funded by the March of Dimes 
were the first to report that drinking alcohol during pregnancy could 
cause fetal alcohol syndrome.
    In the 1980s, March of Dimes research helped lead to the use of 
surfactant to treat respiratory distress syndrome in newborns a finding 
that has saved thousands of lives. In the 1990's the Foundation 
launched a $10 million effort to fight spina bifida and other neural 
tube defects by working to obtain FDA approval to fortify the grain 
supply and teaching health professionals and women about the importance 
of taking folic acid. This national folic acid campaign is showing 
impressive results--the National Center for Health Statistics has 
reported that the rate of neural tube birth defects has decreased 26 
percent between 1995 and 2001.
    We have worked diligently to fulfill our mission--to improve the 
health of infants and children by preventing birth defects and infant 
mortality--in a number of ways. Our expense allocations are comprised 
of general operational, fund raising, and the largest percentage--75.8 
percent--for program services. Those services are organized into three 
categories: Education, 47 percent; Community Services, 28.6 percent; 
and Research, 24.4 percent.
    Over the last 68 years, we at the March of Dimes have learned 
important lessons about initiating and sustaining a national campaign 
that achieves positive measurable results for families and children. 
Using this experience, in January of 2003, we launched a campaign to 
address another issue of central importance to the Foundation's 
mission--preterm birth.
    The March of Dimes Prematurity Campaign--a 5-year, $75 million 
effort--is a very significant commitment for the Foundation. According 
to data from the Centers for Disease Control and Prevention (CDC), 
prematurity is the number one cause of neonatal mortality in the U.S. 
It is the number two cause of infant mortality, and the number one 
cause of mortality among black infants. And still the rate of 
prematurity is increasing. The American College of Obstetricians & 
Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the 
Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) 
are working as partners with the March of Dimes to carry out this 
campaign. In addition, to these three partners, 37 other organizations 
representing government, maternal and child health education and 
research, and trade and industry associations have joined this campaign 
as members of the National Prematurity Campaign Alliance.
    Recently, the CDC reported the first rise in infant mortality since 
1958. The nation's infant mortality rate in 2002 was 7.0 per 1,000 
births, which is up from 6.8 in 2001. Whether 2002 will be a blip or 
not, it is a wake-up call regarding a critical prenatal health issue. 
The infant mortality rate has not declined in a significant way for the 
past several years. And it is important to note that the 2002 increase 
is due to birth defects, prematurity/low birth weight, and 
complications during birth.
    It is one of the goals of our Campaign to decrease the rate of 
preterm birth in the U.S. by at least 15 percent. This is going to be 
difficult as the national rate continues to rise. In 2002, 12.1 percent 
of babies were preterm--before 37 completed weeks of gestation. This is 
a very disturbing 29 percent increase since 1981. Premature birth takes 
a disproportionate toll on racial/ethnic minority populations. In 2002, 
the highest preterm birth rates are among Non-Hispanic Black infants 
where 17.7 percent were born preterm across the Nation.
    An analysis of Agency for Healthcare Research and Quality data by 
the March of Dimes found that on average, 2001 hospital charges in the 
U.S. for newborns without complications were $1,300. By contrast, 
charges for those infants with a principal diagnosis of prematurity 
averaged $75,000. In 2001, hospital charges for all infants totaled 
$29.3 billion. Nearly half of that total--$13.6 billion--was for babies 
diagnosed as premature. In other words, nearly 50 percent of the total 
charges for infant hospital stays in 2001 were for babies who were born 
too soon or too small. Employers, along with private health plans, 
assume half the total hospital bill for prematurity. The Federal/State 
Medicaid program also bears a large share of the cost.
    Other costs, however, are more difficult to quantify. Such as those 
incurred after a baby leaves the NICU. About 25 percent of the youngest 
and smallest babies live with long-term health problems, including 
cerebral palsy, developmental delay, blindness, and other chronic 
conditions. A study published in 2002 by the Journal of the American 
Medical Association found that children born prematurely are at greater 
risk for lower cognitive test scores and behavioral problems when 
compared to full-term children.

                   FEDERAL GOVERNMENT'S ROLE--S. 1726

    As significant as we believe the March of Dimes Campaign will be, 
the Foundation is a non-profit organization with limited resources. 
Success in reducing the incidence of prematurity requires a commitment 
from the Federal Government as well. The Foundation was pleased to work 
with the Chairman and Ranking Member to develop S. 1726, the 
Prematurity Research Expansion and Education for Mothers who deliver 
Infants Early (PREEMIE Act) and hopes that the bill will be reported by 
the committee and approved by the Senate this year.
    This legislation provides for much needed Federal support of 
research and education that will help reduce the rates of preterm labor 
and delivery. Specifically, the PREEMIE Act calls on the National 
Institutes of Health (NIH) and the Centers for Disease Control and 
Prevention (CDC) to ``expand, intensify and coordinate'' research 
related to prematurity. It formally authorizes the Maternal Fetal 
Medicine Unit Network--which includes university-based clinical centers 
and a data coordination center--through which perinatal studies to 
improve maternal and fetal outcome are conducted. Also authorized is 
the Neonatal Research Network to improve the care and outcome of 
neonates, especially very-low birthweight infants. These NICHD 
supported networks address major problem areas with randomized 
controlled trials, studies, and outcomes research.
    The bill also adds a section on assisted reproductive technologies 
to the National Children's Study, calls for an analysis of the 
relationship between prematurity and birth defects and developmental 
disabilities and requests an Institute of Medicine (IOM) report on the 
health and economic consequences of preterm birth.
    To stimulate more consistent collaboration among HHS agencies and 
to better target promising research activities being conducted under 
the auspices of various Federal agencies, the PREEMIE Act codifies the 
Interagency Coordinating Council on Prematurity and Low Birthweight 
(LBW) and gives it specific activities. The Council would include 
representatives of Department of Health and Human Services agencies 
that conduct prematurity-related activities and outside organizations 
with an interest in prematurity. Proposed activities include:
     A Surgeon's General Conference on prematurity and LBW.
     Development of a consensus research plan for HHS on 
prematurity and LBW.
     Regular reporting to the HHS Secretary and appropriate 
committees of Congress on current HHS activities relating to 
prematurity and LBW (including the recommendations from a Surgeon 
General's Conference).
    The PREEMIE Act also authorizes several demonstration projects to 
help disseminate information on prematurity to health professionals and 
other providers, as well as to the public. Projects would include 
development of information on the signs of preterm labor; screening for 
and treating infections; counseling on optimal weight and good 
nutrition (including folic acid); smoking cessation education and 
counseling; and stress management. In addition it calls for Federal 
agencies to conduct programs to improve treatment and outcomes for 
babies born prematurely. The bill also establishes grants for NICU 
family support programs--which respond to the needs of families with 
babies in the Neonatal Intensive Care Units (NICUs) during 
hospitalization, the transition home and in the event of a newborn's 
death.
    The ``PREEMIE Act'' is needed to expand resources for research into 
the causes of prematurity. March of Dimes volunteers and staff look 
forward to working with the Senate and House sponsors, and our 
Prematurity Campaign Partners--the Academy of Pediatrics, the American 
College of Obstetrics and Gynecology, and the Association of Women's 
Health, Obstetric and Neonatal Nurses--to obtain swift approval of this 
measure.
    Another important piece of legislation, S. 1734, the Prevent 
Prematurity and Improve Child Health Act proposes to increase access to 
health insurance for uninsured women, infants and children. 
Specifically it:
     Gives States the option to include pregnant women in the 
State Children's Health Insurance Program (SCHIP);
     Gives States the option to cover legal immigrant pregnant 
women in SCHIP and Medicaid;
     Removes the exemption for tobacco cessation coverage under 
Medicaid;
     Encourages States to include smoking cessation as a core 
performance measure in the Maternal and Child Health Block Grant;
     Gives States the option to extend beyond 60 days post 
partum the period during which family planning services are provided to 
women enrolled in Medicaid; and
     Gives States the option to use SCHIP funds to supplement 
benefits provided through private insurance to children with special 
health care needs.
    Health insurance coverage and access to medical care are among the 
most important factors related to positive medical outcomes. Data from 
the Census Bureau show that for the aggregate years 2000-2002, nearly 
19 percent of women of childbearing age were uninsured in the U.S. 
Among children under age 19 in the U.S., more than 12 percent--or about 
1 in 8 children--had no health insurance during the 2000-2002 period. 
The reasons are many, and they are complex, but the outcome is the 
same: life is not beginning on equal footing.
    The IOM report issued in January of 2004 stated that the 43 million 
currently uninsured Americans don't get needed medical care, so, to 
quote the report, ``they tend to be sicker and die sooner.'' This 
unconscionable situation cannot continue. Insurance is necessary not 
only to prevent preterm birth but to enhance maternal and child health 
generally.
    Prematurity is a growing, devastating problem. We know the road 
ahead of us is long. And we also know we cannot travel it alone. That 
is why we especially appreciate the commitment of the Chairman and 
Ranking Member, Senators Alexander and Dodd to improving women and 
infants' health.
    The March of Dimes and its partners can increase awareness of the 
problem of prematurity. We can reduce the tremendous costs generated by 
preterm birth through education, counseling, and access to health 
coverage. We can increase our knowledge and understanding of the causes 
of prematurity through research. And--ultimately--we can decrease the 
rate of preterm birth in the U.S.
    But to do so requires a commitment from each of us. And I am 
confident that working together we will be successful.

    Senator Alexander. Dr. Lockwood.
    Dr. Lockwood. I would like to add my really profound thanks 
for the opportunity to talk about prematurity, both from the 
perspective of a physician and also as someone who has spent 
the last 15 years of his research career on the topic as well. 
So I want to thank Chairman Alexander and Ranking Member Dodd 
and Senator Bond and the other Members of the Subcommittee who 
are not here. And I will unfortunately repeat a number of 
things that have been said, but maybe repetition is not so bad 
in this context.
    Premature births, just for definitional sake, are those 
that occur before 37 weeks of pregnancy instead of the usual 
40, and they are the leading cause of infant mortality as well 
as mental retardation, cerebral palsy, lung and 
gastrointestinal damage, and hearing and vision loss in 
children.
    As you have just heard, the March of Dimes estimates that 
premature births result in nearly $14 billion in annual health 
care costs. So clearly, premature birth is a major public 
health challenge.
    Ironically, while much progress has been made over the past 
20 years in understanding the causes of prematurity, there has 
been a 27 percent increase in premature births over the past 
decade. In fact, in 2002, 12.1 percent of births in the United 
States were premature.
    As has also been alluded to, among the major risk factors 
for prematurity are, ironically, a prior premature birth, 
African American race, mothers who are very young and somewhat 
older, underweight or of short stature. Risk factors developing 
during pregnancy include vaginal infections, bleeding and 
discharge, as well as uterine contractions and pelvic pressure. 
But unfortunately, only 30 percent of patients destined to 
deliver preterm can be identified by those risk factors.
    There are a number of biological pathways that are thought 
to be responsible for premature birth. The four that I and my 
colleagues at Yale have been studying include fetal and 
maternal stress, maternal and fetal inflammation, uterine 
bleeding, also known as placental abruption, and excess uterine 
stretch caused by multifetal pregnancies. I would like to 
briefly discuss each of these.
    There is reliable and consistent scientific evidence that 
women with high levels of anxiety and depression have a two-
fold elevated risk of premature birth. However, fetal stress 
caused by placental abnormalities is associated with an even 
stronger, four-fold risk of prematurity.
    We think that maternal and fetal stress account for about 
one-third of all preterm births. Fortunately, most of those 
deliveries occur after 32 weeks, which is a less dangerous 
period. Yet-to-be-identified genetic factors are thought to be 
responsible for either an exaggerated response to stress or 
abnormal development of the placenta.
    Inflammation of the uterus, fetal membranes, and the fetus 
itself has also been linked to prematurity. We believe that 
bacteria or allergens may trigger premature birth by activating 
the fetal and/or immune system, leading to contractions, fetal 
membrane rupture, and cervical dilation.
    While 40 percent of all premature births may be caused by 
inflammation, it appears to be responsible for at least 60 
percent of very early premature births--that is, those 
occurring before 32 weeks--and is more common among African 
American women, which may help account for their nearly twofold 
higher rate of prematurity.
    Unfortunately, we do not know how or why inflammation 
develops in some pregnancies or whether it is caused by a true 
infection or allergic reaction or simply an exaggerated, 
genetically-determined, immunological response to normal 
bacteria or otherwise trivial allergens. Again, genetic 
variations may account for these puzzling findings, and 
research is needed to identify the relevant biological 
mechanisms, determine which women really are at risk, and 
design prevention strategies.
    Bleeding into the wall of the uterus, or placental 
abruption, also appears to trigger prematurity, and we think 
that these abruptions, as they are called, account for one-
quarter of all premature births, but about 40 percent of very 
early ones. However, while we now appreciate the link between 
uterine bleeding and premature birth, we have only limited 
ideas about what causes such bleeding or how it triggers 
premature labor.
    Multifetal pregnancies, including twins, triplets, and 
quadruplets, appear to cause excessive stretching of the uterus 
and cervix, triggering premature labor.
    There has been a surge of multifetal pregnancies over the 
past 20 years, brought on by increased use of fertility 
treatments. While this increase has now plateaued, multifetal 
pregnancies account for 17 percent of all premature births, 
since 60 percent of twins, 90 percent of triplets, and over 95 
percent of quadruplets deliver prematurely.
    However, we do not understand why many women with twins and 
some with triplets deliver near term--and I have certainly seen 
that myself in my practice--while others deliver in their 4th 
month, which I have seen as well. Yet again, we think genetic 
factors may account for this variable response to uterine 
stretch.
    Currently, our ability to identify women at risk from any 
of these four causes is limited. Historical risk factors, as I 
have just shown, and mother's symptoms identify too few women 
to be useful. Recently developed techniques, including 
detection of a short cervix by ultrasound and of a protein 
called fetal fibronectnin in vaginal mucous, produce too many 
false positive results for their use as screening tests.
    And while our diagnostic tools may seem inadequate, so are 
our treatments. As Duane has already pointed out, bed rest has 
been traditionally used in high-risk patients without any 
scientific validation of its efficacy. Anti-contraction 
medications, called tocolytics, prolong pregnancy for 48 hours, 
giving us time to administer steroids that may help mature the 
fetus' lungs, but they do not prevent prematurity. And, despite 
the suspected role played by infection in premature birth, 
antibiotics have also not been shown to prevent prematurity.
    Most recently, several studies have suggested that 
progesterone therapy prolongs pregnancy in high-risk patients. 
Progesterone may work by opposing the effects of stress 
hormones, reducing inflammation, preventing uterine bleeding, 
and minimizing uterine stretch, affecting each of the potential 
causes of prematurity. However, a number of questions remain 
about its use, such as when in pregnancy it needs to be 
started, whether it can be used with multifetal pregnancies, 
and at what dose.
    Clearly there is a pressing need for further research into 
this problem, yet the extent of current research is minimum.
    There are multiple reasons for this paucity of research. 
First, the branch of the NIH with jurisdiction over this type 
of research has been chronically underfunded for years. The 
National Institute of Child Health and Human Development, or 
the NICHD, receives less than 5 percent of the total NIH 
budget, yet it is supposed to support almost all research into 
maternal, child and fetal health problems. If you want to think 
of it from this perspective, about 5 percent of the 5 percent 
is used for prematurity research.
    The current Federal budget deficit has exacerbated this 
problem. The NICHD now plans to fund research grants receiving 
study section scores up to the 12.5 percentile, whereas in the 
past 5 years, they have funded research grants up to the 21st 
percentile. To put that into simpler terms, roughly 90 percent 
of the grant applications going to NICHD will not be funded in 
the current climate.
    Second, there has been a virtual absence of industry-
sponsored research because of concerns about liability, costs, 
and adverse publicity.
    The final reason for this dearth of prematurity research is 
the precarious financial status of academic departments of 
obstetrics and gynecology. After seeing substantial reductions 
in clinical revenues and soaring malpractice insurance premiums 
over the past 10 years, many university-based departments of 
ob-gyn have no financial ability to support the preliminary 
research results needed to justify grant applications.
    As an example, each professional liability insurance 
premium for an academic obstetrician at Yale next year will be 
over $100,000.
    Indeed, nearly half of university-based departments of ob-
gyn have no NIH-funded research at all.
    The Society for Gynecological Investigation, our primary 
ob-gyn research organization, the Society of Maternal-Fetal 
Medicine, the leading organization of high-risk obstetricians, 
the March of Dimes, and the American College of Obstetricians 
and Gynecologists all strongly support efforts to increase 
funding for prematurity research and my comments here today.
    Based on my experience as a clinician, departmental chair, 
and both March of Dimes and NIH-funded investigator, I urge 
Congress to authorize new funding to be administered through 
the NICHD for research targeted to prematurity.
    Specifically, I would urge new funding to create centers of 
excellence in prematurity research focusing on basic and 
translational, not just clinical, research into the fundamental 
genetic, biological, and environmental causes of prematurity, 
and second, new funding for research to address the underlying 
causes of the substantial disparity in rates of very early 
premature birth between African American women and those of 
other races.
    I would also recommend that Congress provide financial 
incentives and liability protection to pharmaceutical companies 
to develop new drugs to prevent prematurity.
    More than 460,000 babies are born premature each year, and 
80,000 are born before 32 weeks. These latter babies are 70 
times more likely to die in their first year of life, and as I 
noted previously, if they survive, they are far more likely to 
suffer handicaps. While the plan I have suggested admittedly 
requires a substantial investment, the yield on this investment 
will be extraordinary.
    Thank you very much for this time.
    Senator Alexander. Thank you, Dr. Lockwood.
    [The prepared statement of Dr. Lockwood follows:]

            Prepared Statement of Charles J. Lockwood, M.D.

    Premature births (PMBs) are deliveries that occur prior to 37 weeks 
of pregnancy instead of the usual 40. They are a leading cause of 
infant mortality, as well as mental retardation, cerebral palsy, lung 
and gastrointestinal damage, and hearing and vision loss in children.
    The March of Dimes has estimated that PMBs result in nearly $14 
billion in annual health care costs. Thus, PMB is a major public health 
challenge.
    Ironically, while much progress has been made over the past 20 
years in understanding the causes of prematurity, there has been a 27 
percent increase in PMBs over the past 2 decades and, in 2002, 12.1 
percent of births in the United States were premature.
    Among the major risk factors for prematurity are a prior PMB, 
African-American race, and mothers who are very young, underweight or 
of short stature. Risk factors developing during pregnancy include 
vaginal infections, bleeding and discharge, as well as uterine 
contractions and pelvic pressure. Unfortunately, only 30 percent of 
patients destined to deliver preterm can be identified using these risk 
factors.
    A number of biological pathways are thought to be responsible for 
PMB. The four that I and my colleagues at Yale have been studying 
include:
     fetal and maternal stress;
     maternal and fetal inflammation;
     uterine bleeding, also known as placental abruption; and
     excess uterine stretch caused by multifetal pregnancies.
    There is reliable and consistent scientific evidence that women 
with high levels of anxiety and depression have a two-fold elevated 
risk of PMB. However fetal stress, caused by placental abnormalities is 
associated with an even stronger, four-fold increased risk of PMB.
    We think that maternal and fetal stress account for about a third 
of all PMBs. Fortunately most of these deliveries occur after 32 weeks, 
which is a less dangerous period. Yet to be identified genetic factors 
are thought to be responsible for either an exaggerated response to 
stress and/or abnormal development of the placenta.
    Inflammation of the uterus, fetal membranes, and the fetus itself, 
has also been linked to PMB. We believe that bacteria or allergens may 
trigger PMB by activating the fetal and/or maternal immune system 
leading to contractions, fetal membrane rupture, and cervical dilation.
    While 40 percent of all PMBs may be caused by inflammation, it 
appears responsible for at least 60 percent of PMBs occurring before 32 
weeks, and is more common among African-American women, which may help 
account for their nearly two-fold higher rate of prematurity.
    Unfortunately, we do not know how or why inflammation develops in 
some pregnancies or whether it is caused by a true infection or 
allergic reaction or simply an exaggerated immununologic response to 
normal bacteria or otherwise trivial allergens.
    Again genetic variations may account for these puzzling findings 
and research is needed to identify the relevant biological mechanisms; 
to determine which women are at risk; and to design prevention 
strategies.
    Bleeding into the wall of the uterus, or placental abruption, also 
appears to trigger PMB. We think that abruptions account for another 
quarter of all PMBs, including 40 percent of very early ones. However, 
while we now appreciate the link between uterine bleeding and PMB, we 
have only limited ideas about what causes such bleeding or how it 
triggers prematurity.
    Multifetal pregnancies, including twins, triplets, and quadruplets 
appear to cause excessive stretching of the uterus and cervix 
triggering preterm labor.
    There has been a surge of multifetal births in the past 20 years 
brought on by the increased use of fertility treatments. While this 
increase has now plateaued, multifetal pregnancies account for 17 
percent of all PMBs, since 60 percent of twins, 80 percent of triplets 
and over 95 percent of quadruplets deliver prematurely.
    However, we don't understand why many women with twins and some 
with triplets deliver near term while others deliver by their 4th 
month. Yet again we think that genetic factors account for this 
variable response.
    Currently our ability to identify women at risk from any of these 
four causes is limited. Historical risk factors and a mother's symptoms 
identify too few women at risk to be useful. Recently developed 
techniques, including detection of a short cervix by ultrasound, and of 
a protein called fetal fibronectin in vaginal mucous, produce too many 
false positive results for their use as screening tests.
    And while our diagnostic tools are inadequate, so are our 
treatments:
     Bed rest has been traditionally used in high risk patients 
without scientific validation of its efficacy;
     Anti-contraction medications, called tocolytics, prolong 
pregnancy for 48 hours, giving us time to administer steroids to help 
mature the fetus' lung, but they do not prevent prematurity; and
     Despite the suspected role played by infection in PMB, 
antibiotics have not been shown to prevent prematurity.
    Most recently, several studies have suggested that progesterone 
therapy prolongs pregnancy in high-risk patients. Progesterone may work 
by opposing the effects of stress hormones, reducing inflammation, 
preventing uterine bleeding and minimizing uterine stretch. However, a 
number of questions remain about its use, such as when in pregnancy it 
needs to be started, and at what dose.
    Clearly there is a PRESSING need for further research into this 
problem, yet the extent of current research is small.
    There are multiple reasons for this paucity of research.
    Firstly, the branch of the N.I.H. with jurisdiction over this type 
of research has been chronically under-funded for years. The National 
Institute of Child Health and Human Development, or the NICHD, receives 
less than 5 percent of the total NIH budget yet it is supposed to 
support almost all research into maternal, child and fetal health 
problems.
    The current Federal budget deficit has exacerbated the problem. The 
NICHD now plans to fund research grants receiving study section scores 
up to the 12.5 percentile whereas in the past 5 years, they have funded 
research grants up to the 21st percentile.
    Secondly, there has been a virtual absence of industry-sponsored 
research because of concerns about liability, costs and adverse 
publicity.
    The final reason for the dearth of prematurity research is the 
precarious financial status of academic departments of OB/GYN. After 
seeing substantial reductions in clinical revenues and soaring 
malpractice insurance premiums over the past 10 years, many university-
based departments of OB/GYN have no financial ability to support the 
preliminary research results needed to justify subsequent grant 
applications.
    As an example our professional liability insurance premiums for an 
academic obstetrician at Yale next year will be over $100,000.
    Indeed, nearly half of university-based departments of OB/GYN have 
no NIH funded research.
    The Society for Gynecologic Investigation, our primary OB/GYN 
research organization, the March of Dimes and the American College of 
Obstetricians and Gynecologists all strongly support efforts to 
increase funding for prematurity research.
    Based on my experience as a clinician, departmental chair, and both 
March of Dimes and NIH-funded investigator, I urge Congress to 
authorize new funding, to be administered through the NICHD for 
research targeted to prematurity. Specifically I would urge:
    (1) New funding to create centers of excellence in prematurity 
research focusing on basic and translational research into the 
fundamental genetic, biological and environmental causes of 
prematurity; and
    (2) New funding for research to address the causes of the 
substantial disparity in rates of very, early PMB between African-
American women and those of other races.
    I would also recommend that Congress provide financial incentives 
and liability protection to pharmaceutical companies to develop new 
drugs to prevent prematurity.
    More than 460,000 babies are born prematurely each year and 80,000 
are born before 32 weeks. These latter babies are 70 times more likely 
to die in their first year of life, and as I noted previously, if they 
survive they are far more likely to suffer serious handicaps. While the 
plan I have suggested admittedly requires a substantial investment, the 
yield on this investment will be extraordinary.

    Ms. Jordan, welcome.
    Ms. Jordan. Thank you for having me today. I want to thank 
you, Senator Alexander, the Senator from my home State of 
Tennessee, and Senator Dodd. It is quite an honor that you have 
asked me here today to share my family's story.
    I know that those who are here have been able to see my 
beautiful daughter, and she is one of the success stories.
    In the year 2000, I was 35 years old and pregnant, and I 
was happy as can be. It was my lifelong dream. I did everything 
right. I did the pre-, pre-, pre-pregnancy care; I did prenatal 
care. I did not take an aspirin. I did not drink caffeine. I 
did not smoke. I did not drink. I did everything by the book.
    At 25\1/2\-weeks, I had a very severe headache. I went to 
my doctor, thinking that maybe he was going to try to convince 
me to take some aspirin. Instead, he admitted me to the 
hospital. Within 24 hours, I was in labor and delivery, 
surrounded by my doctor, my family, my minister, and a few 
close family and friends. And I was faced with a very difficult 
decision. They told me that I had something called HELLP 
syndrome, which is kind of related to preeclampsia. Basically, 
there is no known cure for HELLP syndrome. The only cure is 
delivery of the child.
    Well, I was just past 25 weeks' pregnancy, so we knew that 
there was very little likelihood that she would survive, and if 
she did, her life would not be what we had dreamed of.
    They gave us a choice--I could induce labor, which would 
probably ensure that she would not make it and would ensure my 
immediate survival, or we were given a choice to take an 
ambulance to a regional trauma hospital, which is the choice 
that we made. We got in the ambulance and went to the trauma 
hospital. We were hoping to get me to 32 weeks of pregnancy. 
Well, that did not happen.
    I did get three rounds of steroids, and it did help develop 
her lungs, as Dr. Lockwood mentioned, so we were grateful for 
that. But just shy of 26 weeks, they told me it was time to 
deliver. Basically, if I had died, they were also going to lose 
my child. I had hoped and dreamed that they could do like in 
the movies and hook me to all sorts of machines and sustain my 
life and help my child to go to 40 weeks of pregnancy. They 
explained to me that that is not how it happens.
    So I was taken to the labor and delivery room at just shy 
of 26 weeks and forced into an emergency Cesarean section. For 
those of you who have not been a part of it, it is not very 
pleasant. They took one arm and strapped it to one side of the 
table, they took another arm and strapped it to the other side. 
They took my feet, put them together and strapped them down to 
the end of the table. I had very little clothes on; I was 
draped; and a gas mask was put over my face.
    I will tell you at that moment you feel like you have 
failed your child in some way because I was not able to have a 
full-term pregnancy. When I closed my eyes, I knew that when I 
woke up, there was a tremendous likelihood that my daughter 
would not be there, and if she was there, there was a 
tremendous likelihood that she would have a very difficult 
life.
    Well, I did wake up, and they told me that my daughter had 
been born, and they had determined that although she was only 
one pound and 10 ounces, she was a life worth fighting to save. 
So I was grateful. They told me that there was a 40 to 50 
percent chance that she would not survive. But we continued to 
pray and believe in medical science and the power of prayer 
that there was a chance that my daughter would make it.
    We took it 1 day at a time. Her little head would actually 
fit right in the palm of my hand. Her skin was very thin and 
transparent. We could not really hold her; it was about a month 
before I was actually able to hold her. But I was able to stick 
my little pinky into the isolette that she was in, and her 
hands were so tiny that when she held it, they barely went 
around about 50 percent of my pinky. But that was my way of 
letting her know that I was there.
    She had a little hole between her heart and her lungs, and 
fortunately, there was a medication that had been created that 
was able to close that hole instead of her having to face 
surgery. If the medication had not worked, she would have had 
to go under surgery at one pound, 10 ounces.
    She was on a ventilator because she could not breathe. The 
ventilator was not working. They turned the ventilator setting 
up to the highest setting it could be on, and she blew a hole 
outside of her lungs. Basically, her lungs burst. Her chest 
cavity filled with air. They had to insert tubes in her chest--
and you can see in the picture, it is one of the red tubes. 
They cut a hole in her chest wall and inserted the tube. They 
were not able to give her any anesthesia because she was too 
small, and they were more concerned that the anesthesia would 
kill her; but we knew that we had to get the tube in. She had 
more tubes and wires coming off her body than you could 
possibly imagine.
    Her eyes had been fused shut maybe just a week before she 
was born, but she had two arms, two legs, ten fingers and ten 
toes, and she was the most beautiful thing I had ever seen in 
my whole life.
    And day by day, minute by minute, she got stronger. At 
about 2 months of being in the hospital, they told me that it 
looked like she was going to make it. Now, that did not mean 
that she was going to have a normal life--it just meant that 
she was going to make it, and that was okay for me.
    She got bigger and stronger, and at 4 pounds, 7 ounces, 
this most fabulous physician told me it was time to take her 
home. And I was petrified. She was still on oxygen, and she was 
on a heart monitor. I begged him to just keep her there until 
she was at least in first or second grade. I said if you could 
just keep her long enough for her to be able to sustain 
herself--but he encouraged me, and he told me we could do it.
    So with a huge oxygen tank in hand and a heart monitor to 
make sure that her heart continued to beat and make sure she 
was getting enough oxygen, we took her home. It was not the 
normal homecoming that we had planned on, but we did it.
    Six months after she arrived home, she was off oxygen; in 1 
year, she was off the heart monitor. Whitney is now, as you can 
see from this picture, quite possibly the most beautiful 3-
year-old little girl who has ever walked the face of this 
earth. She has absolutely no repercussions from her early 
birth--and when I say no repercussions, I mean none. That is a 
medical anomaly.
    It is proof that the research efforts of these fabulous 
people that you have heard from are making a tremendous, 
tremendous difference. It is because of that I have the life 
that I had dreamed of, and I have this family. But it was kind 
of a bittersweet thing, because while Whitney made it home, the 
other two babies that were in her corner of the hospital did 
not have such a positive outcome.
    So there is a lot more that needs to be done, and that is 
why I feel so honored to have been able to come and share my 
story, because I wanted you to see that the research does make 
a difference, but there is so much more that needs to be done. 
We need to help save these babies once they are born early, but 
far more important, we just need to prevent this from happening 
in the first place.
    So on behalf of my wonderful husband Sam and my beautiful 
daughter Whitney and from the bottom of my heart, I thank you 
for what you are here to do today.
    Thank you very much.
    [The prepared statement of Ms. Jordan follows:]

               Prepared Statement of Kelly Bolton Jordan

    I would like to start by thanking Senator Alexander, my Senator 
from the State of Tennessee, and Senator Dodd for holding this hearing 
and inviting me to share my family's experience.
    I was a healthy 35-year-old when I became pregnant with my little 
girl, Whitney. I received prepregnancy care and when I became pregnant 
I started prenatal care immediately. I followed all the traditional 
pregnancy advice--healthy eating habits, regular visits to my 
obstetrician, no smoking, no drinking. Through my 6th month, I had a 
perfectly normal pregnancy.
    At 6\1/2\ months of pregnancy (25\1/2\ weeks), I developed a 
syndrome related to Preeclampsia, called HELLP (a syndrome 
characterized by hemolysis, elevated liver enzyme levels and a low 
platelet count). The doctors had no information on the cause of my 
illness and there was no way to prevent it. This turned into a life-
threatening illness and my husband and I had some very difficult 
decisions to make. The only way to improve my condition would have been 
to induce labor when I first entered the hospital, but we were told 
that our baby would have almost no chance of survival. I asked the 
doctors to fight with everything they had to save her and not to be as 
concerned with my survival, but they told me that if I were to die, my 
baby would as well. It was a delicate balancing act, trying to keep me 
alive and giving her more time to grow inside of me. I was given 3 
rounds of steroids to speed up her lung development, but after 5 days, 
I took a turn for the worse and the doctors had to do an emergency 
cesarean section to save both of us. We knew that our baby could have 
major health problems and that I could have died, but we never wavered 
in putting her needs above mine. I was not looking for a perfect 
child--I just wanted to save the one inside of me.
    Whitney was born on October 11, 2000--3\1/2\ months early. She 
weighed just 1 lb. 10 oz. My husband and I were warned that Whitney's 
medical prognosis was bleak. Initially, we were told that Whitney had a 
40-50 percent chance of survival. If Whitney was to live, it was likely 
that she would have life-long repercussions from her early arrival.
    Whitney was taken directly to the neonatal intensive care unit 
where her tiny fragile body was hooked up to more tubes and lines than 
our eyes could bear. Unable to breathe on her own and with terribly 
underdeveloped lungs, she received surfactant therapy and was on a 
ventilator for over a month. Whitney was pricked so many times that her 
little feet became human pincushions.
    When I touched her for the first time a few days after she was 
born, it was very scary--she was so fragile and could not tolerate 
stimulation. Her skin was thin and transparent. We could only touch her 
for brief periods and sometimes not at all as she was sensitive to the 
touch. It was more than a month until I could first hold her and even 
then, it was only for minutes at a time so she wouldn't be 
overstimulated.
    During Whitney's 3 months in the NICU, it seemed that we took one 
step back for every two steps forward. At birth, a small hole was found 
between her heart and lungs. She faced surgery that would be quite 
dangerous but, in the end, her condition was treated with medication. 
Then a ventilator blew a hole in one of her delicate lungs and they had 
to open her chest without the aid of anesthesia. You never feel your 
child is out of danger, but after 2 months, we felt she would survive.
    We were at the NICU sometimes several times a day, into the wee 
hours of the night--these were very emotionally trying times. My 
husband and I are both in jobs with wonderful people and some 
flexibility. We did not resume our normal activity until Whitney came 
home from the hospital and even then, we were only operating at partial 
capacity. We were lucky to have understanding employers and incredible 
health insurance. The costs were astounding. Whitney's 3-month hospital 
stay cost about $250,000.
    The other families we encountered during Whitney's NICU experience 
were from all walks of life but all facing the same battle. Parents had 
different reactions to their child's situation. Some parents were 
attentive and doting and others never visited because they were afraid 
of bonding with their sick baby. Another family had limited visits 
because they couldn't afford money for gas or parking to come to the 
hospital. Some of the babies who passed through the NICU during those 3 
months will have lifelong health problems and some, sadly, died.
    Finally, Whitney began to gain weight, one by one the tubes and 
lines were removed, and she was moved to an open bed. The time was 
approaching for her dismissal from the hospital. With supplemental 
oxygen and a heart monitor, we were sent home to raise our beautiful 
little girl. We were overjoyed to bring Whitney home but had lingering 
fears about being sent home with an infant weighing just 4 lbs. 7 oz. 
What if she stopped breathing? What if she did not get enough oxygen? 
What if she had neurological damage? What if her vision was impaired? 
After 6 months, she came off oxygen and then, a year after leaving the 
hospital, she was taken off the heart monitor.
    Whitney is now a healthy, happy 3-year-old and has no repercussions 
from her early birth. She laughs all the time and loves life--a life 
that would not have been possible without the type of medical research 
that others have testified about. Although Whitney's days are now spent 
medicine-and machine-free, other babies are not as lucky. That is why I 
commend the subcommittee for holding this hearing and urge continued 
expansion of research into why preterm birth happens and how to care 
for babies when they are born so small and fragile.

    Senator Dodd. Very good; perfect job.
    Senator Alexander. Well, we ought to shoot fireworks up for 
that.
    Senator Dodd. I was just going to say we can thank you and 
go home; she kind of said it all.
    [Laughter.]
    Senator Alexander. That was beautifully said. Thank you so 
much for telling that story and telling it so beautifully.
    What hospital were you in?
    Ms. Jordan. The regional medical center.
    Senator Alexander. Is that right? And how long before you 
went home with the oxygen machine?
    Ms. Jordan. She was there for 3 months. They kept her about 
2 weeks shy of her due date.
    Senator Alexander. You talked about the other two babies 
who did not have such a good outcome, and you have obviously 
thought about this a lot since then. You talked about how you 
did everything right that you knew to do.
    Looking back, were there some things that you knew to do 
that other mothers do not do? I asked the first panel what were 
the things that a mother should do today, even though it might 
not always prevent prematurity. What is your answer to that 
question today?
    Ms. Jordan. It was prenatal care and pre-pregnancy care. If 
I did not have a physician that I could have picked up the 
phone and called and said, ``I have this really bad headache--
what should I do?'' I would not have gone into the hospital; I 
would have died, and my child would have died if I had not 
sought medical attention.
    So I think there is no replacement for having a good 
physician on your side and having the care of good doctors and 
nurses.
    Senator Alexander. I mentioned earlier that some years 
ago--actually, my wife did this, and Marguerite Sallee, who is 
the staff director of our subcommittee, created a Healthy 
Children's Initiative in our State, and one of the devices for 
that was to try to make sure that every pregnant mother was 
matched with a pediatrician. And the pediatricians in the 
Memphis area where you live volunteered to try to help make 
that happen.
    Anything else besides having the prenatal health care that 
just sticks out to you as advice for pregnant mothers who want 
to try to avoid prematurity based on what you have learned?
    Ms. Jordan. From what I saw--and I was at a regional trauma 
hospital--I was the oldest mother who delivered, and I was 35 
years of age at the time. There were children delivering 
children--12 years old, 13 years old. There were mothers who 
did not know that doing cocaine was going to affect their 
children, did not know smoking would. When I was at the 
hospital, I was horrified to see pregnant women standing 
outside, smoking cigarettes when they were at the trauma 
hospital waiting to deliver their children. I just wanted to 
scream because it seemed so obvious to me.
    I think it is education. In my walk of life, we saw so many 
people from so many different socioeconomic backgrounds, it was 
just a given and assumed that you did not drink, you did not 
smoke; but I think that some people do not have that 
educational background, they do not have access to doctors, and 
they are not surrounded by people who were given the education. 
So I think the education has to come very early on, from 
keeping teenagers from getting pregnant to, if they do get 
pregnant, getting them the proper medical care and education so 
they can have a chance of having healthy births. When Whitney 
was in the hospital, there was a 2\1/2\-pound baby next to her 
that was addicted to cocaine and was having to be weaned from 
cocaine, not to mention all the other lifelong problems that 
she was going to have and be exposed to.
    Senator Alexander. Dr. Lockwood, we heard Ms. Jordan say 
that she did everything right as far as she could tell, yet she 
still had a premature birth, and you talked about research. Are 
there one or two areas--you are a distinguished researcher--
what are the one or two areas of most promising research, in 
your opinion?
    Dr. Lockwood. Let me actually comment about the frustration 
that many of us have, similar to your frustration, in that it 
is not clear that prenatal care actually reduces prematurity, 
and there are studies to suggest that it does not.
    Smoking certainly lowers birth weight, but it is not so 
clear that it actually promotes--I am not advocating smoking, I 
am not here for the tobacco companies--but it is not so clear 
that it actually reduces the occurrences of prematurity, and it 
actually does reduce the occurrence of preeclampsia and HELLP 
syndrome. But again, there are plenty of bad things associated 
with smoking--do not take this the wrong way.
    And you can go down the list of all the things that Duane 
Alexander mentioned and point out that at best they would have 
a marginal effect on prematurity rates.
    I think that if you do not understand the fundamental 
causes of a problem, it is very, very difficult to prevent it. 
It would be like asking me 150 years ago how do we prevent TB--
well, put people out in the sunshine and give them fresh air. 
We just do not know in the vast majority of cases.
    To answer your question, the two areas that I think are 
absolutely vital for study are the basic underlying biochemical 
mechanisms that lead to prematurity--each of those pathways, we 
know more and more about but not nearly enough--and the 
genetics. Much of what underpins the occurrence of prematurity 
is genetic, and if we can better understand that and the 
genetics of the disorders that are related to prematurity by 
having common placental abnormalities like preeclampsia, HELLP 
syndrome, and fetal growth restriction, we will be able, I 
think, to far better address the issue and have real 
substantive cures and preventive measures in the next few 
years.
    I do not mean to be so vague, but there is not any answer 
to your question, and we really do not know----
    Senator Alexander. That is not vague. That is very 
precise--the answer is we do not know.
    Dr. Lockwood [continuing]. We really do not know.
    Senator Alexander. There is a great deal we do not know.
    I have one other question, and then I will let--we are 
going to have to wrap up in 5 or 10 minutes--I will let Senator 
Dodd finish the questioning. But let me ask you, Dr. Lockwood--
you mentioned that your medical malpractice costs for academic 
obstetricians--that means those who are at the university and 
who occasionally deliver babies but not regularly--is that 
right----
    Dr. Lockwood. That is correct.
    Senator Alexander [continuing]. --cost you $100,000 a year.
    Dr. Lockwood. Will cost us; right.
    Senator Alexander. We have a difference of opinion in the 
U.S. Senate about how to fix that, but putting aside the 
solution for just a moment, do you want to say anything else 
about the severity of the problem and the consequences of the 
failure to fix the rising cost of medical malpractice?
    Dr. Lockwood. I will do it in the context of prematurity, 
in the spirit of bipartisanship here, rather than talk about--
--
    Senator Alexander. You can do it in a scientific way--just 
tell us the truth about it. We will handle the politics.
    Dr. Lockwood [continuing]. The bottom line is that we need 
relief, frankly, and what we propose, the Society for 
Gynecological Investigation, is that the Federal Government 
support a proportion of a malpractice premium for an 
academician--for an ob, for example, in an academic setting--as 
a percent of their grant. So if they are 50 percent on an RO1 
from the NICHD, 50 percent of their premium would be paid from 
additional money to support that research--because without 
doing that, we know for a fact that in 4 years, our malpractice 
premiums per obstetrician will be $169,000, which means there 
is no way that a young physician scientist can in any way, 
shape, or form do anything but clinical care just to pay the 
price of his or her premium. So it is going to absolutely 
destroy the ability, particularly in obstetrics--not quite as 
bad in gynecology--to do good perinatal research, whether it is 
clinical, whether it is basic or translational. It is crippling 
academic departments, because we do not make that much money. 
Our patients are generally Medicaid patients, we do not get 
much reimbursement, and our patients are complicated--a lot of 
very complicated cases are seen by full-time, high-risk 
obstetricians in an academic setting--so they do not generate 
much clinical income, and if they are expected to spend 3 days 
in a lab and not generate any clinical income during that time, 
and since these premiums are not prorated to the amount of 
effort made, it will actually destroy academic obstetrics in 
this country.
    Senator Alexander. Thank you.
    Senator Dodd, why don't you finish the questioning, and 
then we will try to wrap up?
    Senator Dodd. Thanks very much, and let me thank all three 
of you--and again, Ms. Jordan, you were terrific. And I have 
tremendous appreciation for Dr. Howse and my constituent, Dr. 
Lockwood, and their wonderful testimony. But as we all know, we 
all love a story. When we get through all the data and material 
and the scientific research and so on, it all comes down to 
you--and Whitney--and that is really what this is all about in 
many, many ways. So I am very grateful to you. It is not easy 
to come up here and go through stories like this, but the fact 
that you have really helps tremendously and brings home the 
point. So I am very grateful to you.
    First of all, Dr. Howse--just a ball park--could you give 
us some idea--we have all been talking around this today--of 
the cost of prematurity. I do not know if there has been a 
broad macro answer that has ever come up from the March of 
Dimes--obviously the case of Whitney, we have a very good 
outcome, but as you point out, and Ms. Jordan does as well and 
Dr. Lockwood has, obviously, for I guess the majority of 
children who are born premature, the result that Whitney has 
had is not the norm. So there is a cost that goes beyond the 
child leaving the hospital and going back home.
    Do you have any idea that you can put a number on what the 
estimate in cost is as a result of failing to come up with some 
answers on the causes of prematurity?
    Ms. Howse. It is a tough number to get to. I think if you 
start from the base of $13.6 billion just for the 
hospitalization, for the labor and delivery and that initial 
hospital stay, if you have that as a base----
    Senator Dodd. That is for the 480,000 premature births.
    Ms. Howse [continuing]. That is for the babies with the 
primary diagnosis of prematurity, for their hospital stay.
    Senator Dodd. And that cost on an annual basis is over $13 
billion.
    Ms. Howse. Yes, $13.6 billion for the hospital stay. Now, 
that is just for labor and delivery and the stay in the NICU. 
That recurs every year because this is a problem that so far we 
have not figured out how to start----
    Senator Dodd. Can I ask you a naive question? Just to put 
it in context, what would be the comparable cost of 480,000 
babies coming to term, just to give us some sense? Do you know 
what that would be?
    Ms. Howse [continuing]. Well, roughly, the number for the 
hospital cost just total for all kids is about $29 billion, so 
the 12 percent of the babies born premature accounts for half 
of the annual hospitalizations.
    Senator Alexander. And if I may interrupt, you said 
earlier, did you not, that $1,300 is the average cost for a 
baby born at term.
    Ms. Howse. Yes, per baby.
    Senator Alexander. Per baby. And $75,000 is the cost 
associated with prematurity, which is----
    Senator Dodd. Breathtaking.
    Ms. Howse. Right.
    Senator Alexander [continuing]. Excuse me for interrupting.
    Senator Dodd. No, no. I am glad you made that point.
    Ms. Howse. It is a staggering difference.
    And then, Senator, there are a lot of different studies and 
metrics that are used to try to determine the lifetime cost of 
a disability. That is the kind of metric that we start getting 
into, so you have to add productivity and chronic health costs, 
special education costs, and so forth. I think many people 
would perhaps settle on a figure somewhere between $250,000 and 
$500,000 a year to support the most severe consequence of 
prematurity--lifelong cost.
    Senator Dodd. That is breathtaking in its scope, and I will 
come back, Dr. Lockwood, in a minute to the 5 percent of 5 
percent, which I think was a pretty startling moment in your 
testimony.
    But I was curious, Ms. Jordan--you are a well-educated 
women. I gather you and your husband do pretty well financially 
and so forth. I want to get to the support. I loved your 
statement that, after watching how well the doctors had taken 
care of Whitney in the hospital, you wanted her to stay until 
she was in the first or second grade.
    Ms. Jordan. Oh, yes.
    Senator Dodd. I can relate to that in many ways. But you 
did get home, and you went through several months, obviously, 
with the oxygen and the heart monitors and so forth. How much 
support did you get, outside what you and your family could 
obviously provide because of your own circumstances, but from 
the hospital itself or from others in the area? And I want to 
get to the point, Dr. Howse, about what would happen to a 
person not in Ms. Jordan's situation, and how much support 
given a similar situation, particularly the numbers that we are 
talking about and the people we are talking about and the 
profile shared with us earlier, how much support does an 
individual leaving get today who would not necessarily have the 
ability that Ms. Jordan and her husband have.
    Ms. Jordan. To answer your question, Whitney's stay was 
$250,000, by the way, because she was one of the sickest of 
babies. We are fortunate to live in Tennessee, where we have a 
program called Tennessee Early Intervention, and it is a 
fabulous program. So that when Whitney came home, we had many 
resources that we could reach out to to help make sure she was 
developing like she should.
    Our health insurance--I had a fabulous employer, Merrill 
Lynch--was Blue Cross, Blue Shield that provided nursing care 
to come to the home several times a day to make sure that she 
was getting oxygen and the heart monitor was working and that 
sort of thing. Without health care coverage, I do not know 
where we would have been, without Tennessee Early Intervention.
    As far as education upon leaving the hospital, there was 
really none other than that which you would beg to have. When 
you check out of a hospital with a 4-pound baby, they do not 
give you a pamphlet on how to raise her. There is no 
instruction manual that comes. So it required a lot of research 
and a lot of looking and a lot of asking. So there was very 
little education.
    Senator Dodd. So you had a good health care policy, on the 
$250,000 hospital cost, that picked up most of that?
    Ms. Jordan. It did cover almost every dime of it other than 
a couple of hundred dollar deductible. Now, that does dip into 
her lifetime benefit--I never dreamed I would have a concern of 
tapping out in a lifetime benefit--but what if Whitney had had 
to stay on a ventilator, or what if she had had $250,000 to 
$500,000 in medical costs each year--we would have quickly run 
out of insurance, and I do not know where we would have turned.
    Senator Dodd. Yes, exactly. I am thinking, because 
obviously given the profile of the normal case, you are talking 
about an overwhelming majority who have no health insurance, 
and have to bear those costs. Obviously, people are paying 
higher premium costs and whatever else to pick up those costs.
    Had Whitney been born to a poor mother with no health 
insurance, I presume the hospital in Tennessee would have 
provided her with the same kind of care. That is the great 
story in America, that you get that kind of care, that doctors 
do not sit there and make judgments about whether you have an 
insurance policy or not--but obviously someone pays that bill. 
The bill does not go unpaid. And that is one of the things we 
have not really come to terms with in the Congress of the 
United States about how to face that reality, and we had better 
face it soon, because obviously the costs are staggering.
    Ms. Howse. One of the provisions in this bill that we are 
examining today would really get at that question of parent 
education and parent support to go through the neonatal 
intensive care unit experience, and then also address that 
question of transition from hospital to home, because I think 
this is a situation where we probably have resources out there 
that can support and can facilitate parents' journey in this 
terrible circumstance, but it is really a matter of pulling 
things together and having some statements of best practice and 
having some expectations around what kinds of supports parents 
will need. So that is one of the areas that is addressed in 
your bill as well.
    Senator Dodd. Yes, exactly, and I want to raise the point, 
because I think it is a very important piece of this.
    Dr. Lockwood, very quickly--you may have addressed this in 
your testimony, and if you did, I apologize for not picking up 
on it--we have all obviously heard here about the 
disproportionate incidence of prematurity occurring in the 
minority community, particularly the African American 
community. What have your studies shown about it, and why is 
that the case? Can you add anything more than what we have 
heard?
    Dr. Lockwood. Yes. I think some of this has been touched 
upon, but the rate is about twice the rate in white 
populations. Currently, around 17 percent of all live births to 
African American mothers are preterm. It is an enormous 
problem, and it is a particular problem in very premature 
babies, before 32 weeks, where they have an even more 
disproportionate rate. If they are twofold higher overall, they 
are threefold higher among these very, very premature babies, 
and of course, very often they are less affluent, and it is a 
greater hit, as you have already pointed out.
    If you correct for all socioeconomic factors, if you 
correct for cultural factors, new immigrants and so forth, the 
rate is still substantially higher--at least one-and-a-half, 
almost three-quarters higher. So there clearly are probably 
some biological phenomena. We have a lot of ideas about what 
might be triggering; we may have some new research to suggest 
that there might be a genetic predisposition to overreact to 
sort of benign bacteria that are in the reproductive tract, and 
in that inflammatory reaction, you trigger premature delivery.
    So they are really sort of overreacting, if you will, to 
relatively benign bacteria that are in the wrong place, and I 
think this is an incredibly fertile area--pardon the pun--of 
research, because really, we do have the tools already today to 
block those pathways, and it would make a huge difference if we 
really understood clearly what that pathway was.
    Senator Dodd. Are there clinical trials and studies being 
done? Are there any products that are particularly focused on 
the African American community?
    Dr. Lockwood. I think most of the focus has been on stress, 
and I think it is a mistake, to be honest with you, because I 
think that stress tends to cause late preterm deliveries that 
are not so critical, that do not result in long-term health 
problems. It is the infection and inflammatory pathways that 
seem so critical in that population and that I think we should 
really be focusing like a laser beam on to discern and then to 
begin clinical trials.
    Senator Dodd. Yes. I was quite taken with your 5 percent of 
the 5 percent and the whole issue. Just let me tell you here 
today that I will do what I can talking to our colleagues and 
others to see if we cannot do a better job in that area. 
Obviously, we are promoting this piece of legislation, but 
getting some more resources into this area--it has been 
historically a difficult area because children, particularly 
poor children, are not necessarily great advocates, and we rely 
on people like yourself and the March of Dimes and others to 
make the case--people like Ms. Jordan I suspect might become a 
stronger advocate today having been through what she did on 
behalf of these families.
    But clearly we need to be doing a better job. If you are 
not impressed with anything else, just the economics of this 
are pretty staggering. So I cannot promise you what we are 
likely to get out of this, but I am going to be talking, as I 
am confident that my colleague from Tennessee will--we will 
have some conversations with people about how we might move 
along here and do a little bit better.
    Let me address, as I know you did in your testimony, and I 
have certainly heard a lot from my folks in Connecticut about 
the issue of the malpractice insurance problems. I hear you. 
This is a huge problem, obviously, particularly in an area of 
medicine which is, of all the practices, the least lucrative 
when you start talking about obstetrics and gynecology and 
pediatrics and so forth. In fact, I would not have passed 
anywhere near the legislation we have over 24 years dealing 
with children--never would have passed the Family and Medical 
Leave Act--had it not been for the Academy of Pediatrics--
never. We never would have gotten the child care legislation or 
any major piece of legislation affecting children. The major 
source of support I have had has come from the medical 
professions dealing with children. So I am very sympathetic to 
the work they do.
    Also, coming from the State that is known as ``the 
insurance capital of the world,'' I just find it hard to 
understand why it is, when you look at States that either have 
caps on these costs or ones that do not, the premiums still 
seem to go up. The one difference is in a place like 
California, they not only have a cap on the noneconomic 
damages, but they have a cap on premiums. And it is a big 
enough State that they can get away with it because it is so 
important, but nonetheless, there, they have been able to 
really hold down premiums.
    And again, the insurance industry does not want to hear 
this, but how do you explain why one doctor who may have had a 
questionable record and practice and someone who is working 
primarily as a researcher are charged the same rates? We do not 
do that in the automobile industry, we do not do it in any 
other area of insurance. So clearly, there is an answer to 
this, and if we can get together on it, we have really got to 
find a way to do it, because we are driving people out of these 
very important areas.
    We have got to sit down and work through these things, and 
it requires some time and effort, but my hope is that we can do 
that--we should do it, and we need to do it rather quickly as 
well, in my view. But I appreciate you raising it, because it 
is an important point.
    Mr. Chairman, thank you immensely.
    Senator Alexander. Thank you, Senator Dodd.
    This has been a very good hearing. We have been talking 
about a bill that Senator Dodd and I are cosponsoring, S. 1726, 
the PREEMIE bill. Our goal is to expand research so that we 
understand why some babies come early, and then, second, that 
we help transmit that information to mothers. We have been 
involved with the March of Dimes effort which is going to put a 
high priority on this for the next 5 years; we have heard a lot 
about that. We have heard that there are some things that 
mothers who are pregnant should do--plan their pregnancy if 
they can, take folic acid--these come from Dr. Alexander--have 
a physical exam, do not smoke, get prenatal health care. 
Progesterone seems to help, but then, we hear also that we 
really do not know why most babies come early and that many of 
the things that we thought helped, such as bed rest, may not 
have any effect at all.
    That shows the importance of the research. We have heard 
from Dr. Lockwood that there is not enough research and that 
the costs of medical malpractice insurance are making it more 
difficult for there to be enough start-up research to get NIH 
grants. Ms. Howse pointed out that the average cost of a baby 
born to term is $1,300 for the hospital stay but about $75,000 
for a baby born premature with all the associated costs, which 
is a staggering difference, and both Senator Dodd and I think 
that.
    So I think we are on the right track, and this is a very 
important piece of legislation. I am glad, as Chris said, that 
in the House, it has strong sponsorship. Maybe we can get on 
with it, and it will make us a lot more effective as a country 
if, when we go out to our community health centers to pass out 
information about how to avoid prematurity, we know why babies 
are born premature.
    And Ms. Jordan, let me especially thank you for coming. 
That was a beautiful story, and I would love to meet Whitney 
someday, and I have an idea that I will have that chance sooner 
or later.
    Thank you all very much for coming.
    The hearing is adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

          Prepared Statement of Pediatrix Medical Group, Inc.

    Pediatrix Medical Group, Inc. is pleased to submit this testimony 
for the record in support of S. 1726, the Prematurity Research 
Expansion and Education for Mothers who Deliver Infants Early (the 
PREEMIE Act). Because of Pediatrix's focus on premature and other 
critically sick infants, its size and scope of outreach across the 
United States and Caribbean, and the extensive research conducted by 
the company in the area of preterm births, we believe we are in a 
unique position to comment on the merits of this worthwhile legislation 
as it relates to the issue of prematurity and to encourage swift 
congressional action.
    Pediatrix is the largest neonatal and perinatal physician group in 
the U.S., with over 700 physicians and 325 advanced nurse specialists 
providing direct medical care in over 200 hospitals across the country 
to both premature and critically sick newborns, as well as women with 
high risk pregnancies. Last year, Pediatrix physicians cared for an 
average of 3,000 newborns each day in hospitals in 30 States and Puerto 
Rico.
    Our maternal-fetal medicine specialists care for expectant mothers 
with medical and other surgical complications of pregnancy, while 
Pediatrix's neonatologists provide life-sustaining medical care for 
premature babies or those with serious complications. Pediatrix also 
provides pediatric intensive care, pediatric cardiology, and pediatric 
hospitalist services to sick and critically injured babies and 
children. Finally, in addition to the direct life-sustaining care 
provided by Pediatrix physicians and nurse practitioners in a NICU 
(Neonatal Intensive Care Unit) setting, we also provide both newborn 
hearing screening services and the most advanced and comprehensive 
program for screening metabolic and genetic disorders available for 
newborns. Through these screening programs, we identify problems that 
can occur as frequently as 2/1000 births, and for which early 
identification and treatment can prevent serious health consequences 
such as developmental delay, or even death.
    As an example of the severity of cases handled by our doctors, 18 
percent of newborns treated by Pediatrix in a NICU (Neonatal Intensive 
Care Unit) weigh less than 3 pounds at birth. We know that premature 
babies are significantly more likely to face serious health problems 
following delivery, and our goal is to have all children leave the NICU 
for their homes with the best possible start on life. Pediatrix 
physicians--as well as all neonatologists and maternal fetal medicine 
specialists--understand the terrible toll that having a preterm or 
other critically sick newborn can have on parents and other family 
members.
    Because Pediatrix is in the unique position of treating so many 
premature and other extremely critical ill newborns, as well as 
pregnant women who are most at risk of giving birth to a premature 
baby, it is a leader in the private sector in developing Best Practice 
standards, conducting clinical trials, and engaging in other 
collaborative research efforts to improve health outcomes for premature 
infants. It has tracked the outcomes of more than 180,000 neonatal 
cases in a centralized database using an electronic medical record, 
thereby identifying ways to improve clinical care. Pediatrix research 
has included nutritional needs of very low birth weight babies, causes 
of respiratory failure, and causes of death among near-term newborns.
    The results of this work directly benefit all pregnant women and 
newborns. We deliver applied, evidence-based solutions to health care 
providers to decrease morbidity and mortality of the patients we treat 
through our research. Through newborn screening, we decrease costs 
associated with treatable birth defects.
    To share this knowledge across the broader community of newborn 
care providers, Pediatrix developed an active educational outreach 
program that includes ``Pediatrix University,'' an interactive 
educational website, that now maintains more than 3,800+ registrants 
from 71 countries. Pediatrix is accredited to provide continuing 
education for physicians and nurses. Finally, new knowledge is 
regularly shared with the medical community through presentation and 
publication at peer reviewed medical forums.
    The PREEMIE Act would provide a needed Federal impetus to help 
reach the common goal of reducing the rates of preterm labor and 
delivery. As well, it would promote the use of evidence-based care for 
pregnant women at risk of preterm labor and for those infants born 
preterm.
    Pediatrix has prepared and regularly disseminates parental 
education materials to help prepare parents to understand the workings 
of a NICU. Many of these materials are also available as educational 
content on its the company's website. Understanding how traumatic a 
NICU experience can be for many new parents unfamiliar with a NICU's 
operation, these materials contain easy to understand information on 
various medical tests and procedures, common terms used in a NICU, 
frequently asked questions, and even descriptions of the various health 
care professionals that new parents will likely encounter during their 
newborn's stay in the hospital.
    In addition, Pediatrix is a leading partner in the March of Dimes 
NICU Family Support program, actively working to ensure that parents 
are better equipped to handle the additional emotional stress of having 
their newborn cared for in a NICU and at home. We recognize how 
frightening and confusing the NICU can be for families, and we help 
sponsor the March of Dimes effort to provide emotional and 
informational support to those with a newborn in the NICU. Support for 
ante-partum and high-risk women, parent-to-parent support, sibling 
education and support, and sensitive educational materials address the 
challenges that NICU families may face. We are working with the March 
of Dimes to make the experience more manageable for families in the 
hospital, during the transition home, and in the event of a newborn's 
death, and to make this support more widely available to the many 
children and families in need.
    While Pediatrix is extremely proud of its record in improving 
health outcomes for premature babies, developing practice standards, 
and educating parents and family members to better understand and cope 
with their baby's treatment, we also recognize that much more needs to 
be done. Passage of the PREEMIE Act would foster continued research 
opportunities to address this critical and growing problem in our 
society. As medical advances make life-sustaining treatment a greater 
possibility for more preterm and low birth weight babies, we as 
physicians must continue our efforts to ensure that the health care we 
provide offers our tiniest and most vulnerable patients the best 
possible start on a healthy life.
    Just as important, we need additional research in order to prevent 
preterm births in the first place, and to continue to find new and 
better ways to treat women at risk of giving birth to a premature baby, 
or facing other serious life-threatening medical complications.
    Finally, we know first hand how much pregnant women, new parents, 
and family members need education and support services related to 
prematurity.
    The PREEMIE Act is an important step in our united fight against 
prematurity. Pediatrix is proud to join with other providers, 
researchers and parents in urging swift congressional action of this 
bill.

               Prepared Statement of Joy v. Browne, Ph.D.

    Mr. Chairman and Members of the Subcommittee: I am pleased to 
submit the following testimony on premature babies on behalf of ZERO TO 
THREE. My name is Joy Browne and I am an Associate Professor at the 
University of Colorado Health Sciences Center, Department of Pediatrics 
in Denver Colorado. I am an Infant Development Psychologist working 
with premature infants in neonatal intensive care units (NICUs) and as 
they transition into their communities. I am also a Graduate Fellow of 
the Leadership Development Initiative at ZERO TO THREE. ZERO TO THREE 
is a national non-profit organization that has worked to advance the 
healthy development of America's babies and toddlers for over 25 years. 
I am here to talk to you today about premature infants--the 
developmental risks they face, prevention efforts, and early 
intervention services that may have a positive impact on their 
developmental outcomes. I would like to start by thanking the 
subcommittee for all of their work on behalf of our Nation's premature 
infants and their families.

Developmental Risks for Premature Infants

    Infants born too early are at higher risk than full-term babies for 
medical and developmental complications, which can affect the growing 
baby and family well into childhood. The earlier the birth, the more 
risk of complications. The effects may be not only physical and 
cognitive, ranging from chronic lung disease to feeding problems to 
speech and language difficulties, but may also include socio-emotional 
challenges such as a difficulty responding to caregivers and an 
inability to regulate emotions. Children born prematurely may have 
additional long-term significant physical, cognitive and socio-
emotional challenges that contribute to difficulties in school such as 
reading, doing arithmetic, or sitting still and paying attention to the 
teacher. Parents and professionals also report regulatory disorders, 
anxiety, and problems with peer relationships among prematurely born 
children.

Preventing Prematurity

    Experts used to believe that prevention and intervention before and 
during pregnancy could dramatically reduce prematurity. However, 
despite increased prevention and intervention efforts, the incidence of 
preterm births in the United States actually increased by 14 percent 
between 1990 and 2002. Further, the low birth weight rate is at the 
highest level it has been in 3 decades. More than 485,000 low birth 
weight (less than 5.5 pounds), premature (less than 37 weeks' 
gestation) babies are born each year in the United States. 
Approximately one out of every eight babies (12 percent) is born 
prematurely. African Americans have the highest rate of preterm birth 
in the United States, are two times more likely to have babies with low 
birth weight, and are three times more likely to have very low birth 
weight babies as are Non-Hispanic White mothers.
    The American College of Obstetrics and Gynecology attributes the 
increase in prematurity over the last decade in part to an increase in 
the number of women in the U.S. who are postponing pregnancy and to 
increased use of fertility therapies. Poor nutrition during pregnancy, 
smoking, multiple-birth pregnancies, and infections are also associated 
with prematurity.

Importance of Mental Health and Other Services Beginning in the NICU

    The PREEMIE Act would fund Neonatal Intensive Care Unit (NICU) 
Family Support Programs which would respond to the emotional and 
informational needs of families during the stay of an infant in a 
neonatal intensive care unit, during the transition of the infant to 
the home, and in the event of a newborn death. I want to underscore how 
important it is that early intervention and support services begin as 
early as possible after the baby's birth.
    Nurturing, supportive and consistent relationships that develop 
between parents and their newborns provide the foundation for the 
development of social competence, readiness to learn, and emotional 
security. Time spent in the NICU disrupts the normal interaction 
between parents and their baby. The developing parent/infant 
relationship is typically qualitatively different than if the baby had 
been born at full term. These altered interactions may in turn affect 
the baby's mental health and overall development in all domains. We 
need approaches that help build appropriate, supportive early 
relationships and address the stress created by having a fragile baby 
in an intensive care unit. Appropriate supports include mental health 
services, connecting families with parent-to-parent support groups, 
training staff on supporting parent-infant relationships, and helping 
parents create meaningful moments with their fragile infants.

Early Intervention Services for Premature Infants

    Although the prevention of premature births is a widely held goal, 
the incidence of preterm births continues to rise. Mr. Chairman, I 
applaud the subcommittee's efforts to focus attention on preventing 
prematurity through this hearing and the PREEMIE Act that you and 
Senator Dodd have introduced. This is an important effort. However, we 
still have to promote better outcomes for children and families who we 
know will continue to have to face the consequences of premature birth. 
And here, the news is somewhat better.
    Early intervention services for premature infants, even those that 
begin in the newborn intensive care unit, have shown positive effects 
on both physical and developmental outcomes. Early intervention, in the 
form of assessment, prevention and appropriate intervention is 
extremely important. Many premature infants are not currently eligible 
for early intervention services because developmental difficulties may 
not be evident until school age. Providing monitoring and information 
for families on appropriate development are essential so that the 
earliest intervention services may be initiated and potentially prevent 
emerging cognitive and socio-emotional problems.
    All families with premature infants should receive education and 
support, whether from early intervention or from follow-up clinics. 
Parents of preemies may not only be dealing with the stress of caring 
for a high-risk baby, but they may also already be stressed from the 
high-risk pregnancy as well as the unexpected and/or traumatic birth. 
Parents of preemies require skilled, sensitive assistance from medical 
and mental health professionals to help them access information and 
resources; reduce emotional distress; alleviate fears; sort out 
financial implications and the cost of NICU care; and to help them help 
their children master the challenges that will confront them in the 
NICU and throughout their child's life. All services offered to 
families should demonstrate continuity and carry on long after the date 
of discharge from the hospital.
    I am going to briefly highlight several prevention and early 
intervention programs for premature infants and their families.

Early Head Start
    Congress created Early Head Start in 1994 with strong bipartisan 
support. It is the only Federal program specifically designed to 
improve the early education experiences of low-income babies and 
toddlers. By making pregnant women eligible for the program, Early Head 
Start explicitly recognizes that to reach this goal, services must 
start before birth. The mission of Early Head Start is clear: to 
support healthy prenatal outcomes and enhance intellectual, social and 
emotional development of infants and toddlers to promote later success 
in school and life. One of the most important steps to preventing 
prematurity is to begin prenatal care as early as possible and to 
continue prenatal care throughout pregnancy. Statistics show that early 
and good prenatal care reduces the chance of a premature birth, having 
a small baby, and related deaths during delivery and the neonatal 
period.

Special Supplemental Nutritional Program for Women, Infants, and 
        Children (WIC)
    The Special Supplemental Nutrition Program for Women, Infants and 
Children (WIC), was created to help alleviate the effects of poverty on 
the health of infants, children and pregnant or new mothers. Benefits 
provided to WIC participants are: supplemental nutritious foods; 
nutrition education and counseling at WIC clinics; and screening and 
referrals to other health, welfare, and social services. To receive WIC 
services, participants must be eligible by income (185 percent of the 
Federal poverty level), nutritional risk, and category (either a 
pregnant, breast-feeding, or postpartum woman); an infant under 1 year 
old; or a child under 5 years old. Pregnant women enrolled in WIC have 
fewer premature births, fewer low birth-weight babies, and fewer fetal 
and infant deaths. They also seek prenatal care earlier in their 
pregnancy and consume more of key nutrients such as iron, protein, 
calcium and vitamin C.

Part C of IDEA
    Part C of the Individuals with Disabilities Education Act (IDEA) 
authorizes the Federal support for early intervention programs for 
babies and toddlers with disabilities, and provides Federal assistance 
for States to maintain and implement statewide systems of services for 
eligible children, age birth through 2 years, and their families. Under 
Part C, all participating States and jurisdictions must provide early 
intervention services to any child below age 3 who is experiencing 
developmental delays or has a diagnosed physical or mental condition 
that has a high probability of resulting in a developmental delay. In 
addition, States may choose to provide services for babies and toddlers 
who are ``at-risk'' for serious developmental problems, defined as 
circumstances (including biological or environmental conditions or 
both) that will seriously affect the child's development unless 
interventions are provided. Many States now have systems to identify 
premature infants who are automatically eligible for Part C services 
while they are still in the NICU. Similarly, some States have developed 
an Individualized Family Service Plan (IFSP) specifically for the 
developmental needs of newborns in the NICU, therefore providing 
seamless assessment, referral and intervention services.

Colorado's NICU Liaison Project
    The Colorado NICU Liaison project began as a result of statewide 
collaboration among NICU staff, Part C, the Colorado Department of 
Health's Health Care Programs for Children with Special Needs, graduate 
parents and the Center for Family and Infant Interaction. Infants 
admitted to any of the 29 Colorado NICUs are identified and referred to 
community services. The infants are identified as ``at risk'' based on 
an Interagency Coordinating Council eligibility list of conditions that 
presumed the infant potentially will experience developmental delays. 
The Colorado Consortium of Intensive Care Units was committed to 
providing developmentally appropriate early intervention to infants 
under their care, and to support parents during the stressful time that 
their newborn was in the NICU. Through collaborative work between team 
members consisting of Part C, the Department of Health, hospital staff 
and graduate parents, an IFSP specifically for newborns was developed 
and is now used with all eligible infants. Currently, infants who meet 
the criteria for referral to community supports are referred to a 
community liaison, who assists the parents with identifying appropriate 
strengths and needs of the infant, identifying available community 
supports and resources, and with completing the IFSP. Upon discharge, 
the infant and family are followed by a service coordinator from their 
community. This statewide system has identified and referred over 3,500 
infants since its inception in 1999.

Conclusion

    We must continue to ensure that the prevention of premature births 
is a national priority. During the first years of life, children 
rapidly develop foundational capabilities--cognitive, social and 
emotional--on which subsequent development builds. These years are even 
more important for at-risk infants. Despite increased prenatal care, 
improved nutrition and other efforts aimed at preventing premature 
births, we know that we will continue to have early-born infants, with 
all of the complexities that prematurity brings to their medical and 
developmental outcomes, as well as to the continuing impact on the 
families. We also know that the vulnerability of these babies consists 
of much more than the physiological challenges they experience in the 
NICU; prematurity can affect their cognitive and socio-emotional 
development well into the school years. Therefore, up-to-date medical 
care, early individualized developmental intervention such as the 
Newborn Individualized Care and Assessment Program, and support for 
developing infant-parent relationships can and must begin in the NICU 
and continue into preemies' early years in order for them to experience 
the best outcomes possible. Early Intervention programs such as Early 
Head Start, WIC, Part C and Colorado's NICU Liaison Project can serve 
as protective buffers against the multiple adverse influences that may 
hinder their development in all domains.
    With the subcommittee's help, we have made some gains over the past 
few years in increasing funding for prevention and early intervention 
services for at-risk infants and their families. It is unacceptable 
that our overall policy and funding emphasis requires families and 
providers to wait until children are already behind developmentally 
before significant investments are made to address their needs. I urge 
the subcommittee to change this pattern and invest in at-risk infants 
and toddlers early on, when that investment can have the biggest 
payoff--preventing problems or delays that become more costly to 
ameliorate as the children grow older. We cannot wait until premature 
infants have fallen behind at age 4 and then provide special education 
and intensive prekindergarten services to help them catch up. We know 
how to provide prevention and early intervention to at-risk infants and 
their families that works. Policies and funding must be directed to 
preventing premature births, and supporting the development of those 
babies who do arrive too early. Their families also need programs that 
provide information and support so that they can provide optimal 
cognitive and socio-emotional development for their fragile infant. I 
hope the subcommittee will make that initial investment to ensure that 
premature infants have the services and supports they need so they do 
not fall behind.
    Thank you for your time and for your commitment to our Nation's 
premature infants and their families.

Prepared Statement Of The Association Of Women's Health, Obstetric And 
                            Neonatal Nurses

    The Association of Women's Health, Obstetric and Neonatal Nurses 
(AWHONN) appreciates the opportunity to comment on the Prematurity 
Research Expansion and Education for Mothers who deliver Infants Early 
Act (PREEMIE ACT), as well as the problem of premature birth and low 
birth weight in the United States. AWHONN is a membership organization 
of 22,000 nurses whose mission is to promote the health of women and 
newborns. AWHONN members are registered nurses, nurse practitioners, 
certified nurse-midwives, and clinical nurse specialists who work in 
hospitals, physicians' offices, universities and community clinics 
across North America as well as in the Armed Forces around the world.
    AWHONN is a committed partner in the campaign to increase public 
awareness of the problems of prematurity and to reach the Healthy 
People 2010 goal of decreasing the preterm birth rate by at least 15 
percent. A partner in the March of Dimes' Prematurity Campaign, AWHONN 
launched a Prematurity Resource Center on its website; supported 
legislative efforts to reduce the rate of premature birth, and 
published numerous research and clinical articles in AWHONN's research 
and clinical practice management journals to assist providers in 
meeting the challenge of prematurity.

Premature Birth

    Prematurity, defined by the World Health Organization as a newborn 
with a gestational age of less than 37 weeks, represents a serious and 
growing problem in the United States. Traditionally, prematurity was 
defined as having a low birth weight, or less than 2,500 grams, 
regardless of gestational age. Babies who are born prematurely have not 
yet reached a developmental stage where they are able to function 
independently, usually have immature lungs, and are very prone to 
infection because their immune systems are not developed. According to 
the National Center for Health Statistics (NCHS), during a period of 21 
years, from 1981 to 2002, the rate of preterm birth has increased by 29 
percent. In 2002, the number of babies born prematurely reached a 
record high 480,812, or 1 in 8 newborns.\1\
---------------------------------------------------------------------------
    \1\ Births: Final Data for 2002. National Vital Statistics Reports. 
Centers for Disease Control and Prevention. Vol. 52, No. 10. December 
17, 2003.
---------------------------------------------------------------------------
    Preterm birth takes a toll on families and the health care 
providers who work to save these fragile children. Preterm birth 
accounts for 23 percent of neonatal deaths in the 1st month of life. 
Premature babies who survive usually suffer lifelong consequences, 
including cerebral palsy, mental retardation, chronic lung disease and 
vision and hearing loss. When born before 34 weeks of pregnancy, babies 
are particularly at-risk to develop respiratory distress syndrome (RDS) 
and experience bleeding in the brain, which can cause pressure in the 
brain and ultimately, brain damage. In addition to the physiologic 
consequences of prematurity, the undue stress and suffering of the 
family whose newborn is isolated in the Neonatal Intensive Care Unit 
(NICU), fighting for its life, cannot be underestimated. Prematurity 
and low birth weight birth also creates a significant financial burden 
in the healthcare delivery system. The March of Dimes estimates that 
charges for hospital stays for infants with any diagnosis of 
prematurity/low birth weight were $11.9 billion in 2000. The average 
lifetime medical costs of a premature baby are conservatively estimated 
at $500,000.

Who is at Risk--Causes of Prematurity

    While the cause of approximately half of all premature birth is 
unknown, we know three groups of women are at greatest risk of preterm 
labor and birth: women who are pregnant with twins, triplets or more; 
women who have had a previous preterm birth; and women with certain 
uterine or cervical abnormalities. According to the March of Dimes, 
certain lifestyle factors put women at greater risks of preterm labor, 
including smoking, late or no preterm care, alcohol consumption, use of 
illegal drugs, domestic violence, lack of social support, high stress 
levels, long working hours with long periods of standing, and low 
income. Certain medical conditions that may increase the risk of 
preterm labor include premature rupture of the membranes (the sac 
inside the uterus that holds the baby breaks too soon), urinary tract 
infections, vaginal infections, sexually transmitted diseases, high 
blood pressure, diabetes, clotting disorders, obesity, being 
underweight before pregnancy, short time period between pregnancies 
(less than 6-9 months between birth and beginning of the next 
pregnancy), and bleeding from the vagina.
    It is also significant to highlight how rates of premature birth 
vary by race/ethnicity. The Centers for Disease Control and Prevention 
(CDC) report that the percentage of premature births among African 
American women, 17.7 percent, is significantly higher than that of all 
other races, with the average at 12.1 percent.\2\ Prematurity/low birth 
weight is the leading cause of death for African American infants.
---------------------------------------------------------------------------
    \2\ The National Center for Health Statistics' National Vital 
Statistics Report on Births 2003.
---------------------------------------------------------------------------

Current Research/Prevention Activities

    The current prematurity research portfolio has yielded critical 
information that has helped health care providers deliver better 
treatment for women suffering preterm birth and their critically ill 
newborns. For example, in 2003 the National Institutes of Health (NIH) 
reported in the New England Journal of Medicine that weekly injections 
of 17-hydroxy-progesterone can reduce preterm birth by one-third among 
women at increased risk of preterm delivery because they had previously 
had a preterm delivery. CDC research activities include study of new 
methods that can be used for mass screening and early detection, 
pharmacological treatments for preterm birth prevention, and narrowing 
the high risk of preterm delivery among African American women. CDC's 
Pregnancy Risk Assessment Monitoring Survey (PRAMS) initiative collects 
information on self-reported maternal behaviors and experiences that 
occur before, during, and shortly after pregnancy. The goal of the 
project is to reduce adverse outcomes including premature birth and low 
birth weight.
    While our ability to identify women who are at-risk for premature 
birth has improved dramatically through research and risk assessment, 
there remains no therapeutic regimen that has proven effective in 
prolonging pregnancy for more than a few days or improving neonatal 
outcomes. In fact, as reported by the CDC, the exact biologic mechanism 
for normal labor at term is not yet known and the mechanisms for 
preterm delivery are even more elusive. Current research shows promise, 
but both inadequate research funding and disjointed research efforts 
remain very real barriers to making the necessary scientific 
advancements that will result in fewer premature babies. An expanded 
and coordinated targeted research effort is needed to achieve the goal 
of preventing premature birth. The escalating numbers of premature 
births and the associated health care and emotional costs clearly 
demonstrate the need for a more significant investment into research to 
stop the growing epidemic of prematurity.

The PREEMIE Act

    In light of the severity of the problem, the rising frequency and 
the inadequacy of existing data and research, AWHONN urges the Congress 
to pass S. 1726, the PREEMIE Act. This legislation could drastically 
reduce the number of babies who are born too early and improve the 
health care community's ability to care for those who are. The PREEMIE 
Act would: investigate the causes of premature birth; identify the 
factors that make premature birth more prevalent in the African 
American community; educate the public and health care providers about 
premature birth; and promote standards of care to reduce pre-term labor 
and premature births.
    The bill also calls upon the Director of the CDC to conduct a 
review of the PRAMS survey to ensure that it ``includes information 
relative to medical care and intervention received, in order to track 
pregnancy outcomes and reduce instances of preterm birth.'' This survey 
is vital for collecting the data necessary to understanding preterm 
birth and neonatal outcomes, as well as for helping health 
professionals incorporate the latest research findings into their 
standards of practice. The CDC has indicated that there are currently 
gaps in its research, including the need to expand PRAMS from 31 States 
to all or nearly all 50 States, which would enable the program to give 
national estimates. AWHONN nurse members deliver care in a wide range 
of clinical sites that care for women and their families, or almost the 
entire breadth of the PRAMS data collection period. The knowledge 
gleaned through the expansion of the PRAMS survey will be directly 
beneficial to these nurses working with these special patients. We must 
invest the necessary funding to expand the PRAMS initiative and improve 
the cache of data available on preterm birth.
    We are also pleased to see that this legislation calls for an 
Institute of Medicine (IOM) study on the health and economic 
consequences of preterm birth. The IOM would be directed to ``assess 
the direct and indirect costs associated with premature birth, 
including morbidity, disability, and mortality.'' The study's focus on 
cost is significant in a time when health care delivery costs may 
indirectly affect health outcomes. Every day that a premature birth can 
be delayed saves money, and nursing research studies published in the 
Journal of Obstetric, Gynecologic & Neonatal Nursing bear this out.
    Changes in perinatal care practices such as antibiotic treatment, 
surfactant therapy, and use of ventilation in the delivery room, have 
been influential in reducing neonatal mortality rates.\3\ The use of 
prenatal interventions such as antenatal steroids, tocolytic therapy, 
and antibiotics for ruptured membranes can delay premature birth by 
hours, days and even weeks, and can have a marked impact on neonatal 
survivability. Prenatal interventions that delay premature birth can 
also result in significant savings for the care of premature/low birth 
weight newborns, when measured in health care dollars. According to the 
Journal of Obstetric, Gynecologic & Neonatal Nursing, prenatal 
interventions that delay premature birth and affect a shift upward in 
birth weight of 250g for newborns weighing more than 750g result in an 
average savings from $12,000 to $16,000.
---------------------------------------------------------------------------
    \3\ (JOGNN 683).
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    AWHONN is also pleased that the IOM study would provide 
recommendations on the best practices as well as the most promising 
areas of research to further prevention efforts. This represents an 
exciting area where nursing research has already made significant 
contributions. In the last decade, AWHONN has intensified its 
commitment to evidence-based practice through research utilization 
projects, research based protocols, and evidence based guidelines. 
These projects and research initiatives have helped nurses make a 
significant contribution to practice by basing practice protocols on 
scientific data. Nurses have developed interventions to reduce preterm 
birth rates. The effects of bed rest on pregnant women and their 
families have been frequently studied by nurses, and breastfeeding 
issues in relation to preterm birth have long been a topic of study for 
nurse researchers.\4\
---------------------------------------------------------------------------
    \4\ (JOHNN 661-662).
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    The study's provisions relating to public and health care provider 
education and support services are of particular interest to AWHONN. 
Programs that provide information and education to health professionals 
are always welcomed and sorely needed. This legislation takes aim at 
one of our Nation's greatest health problems and what is known to be a 
major contributor to preterm labor and delivery: smoking. AWHONN 
recently launched a wide-ranging research program aimed at improving 
clinical practice delivered by nurses--the goal is to increase the 
likelihood of successful tobacco smoking cessation among childbearing 
women. The Setting Universal Cessation Counseling, Education, and 
Screening Standards (SUCCESS) project is an initiative that addresses 
improving clinical excellence to ensure the future health of newborns. 
Initially funded through a planning grant from the March of Dimes, the 
SUCCESS project is nearing completion and the results will be released 
at the AWHONN Convention in June of 2004. AWHONN built an evidence-
based guideline for pregnant women by using the Surgeon General's five 
A's of smoking cessation (Ask, Advise, Assess, Assist and Arrange) and 
modeled them to educate nurses about smoking and pregnancy and about 
the efficacy of the brief smoking cessation intervention. As part of 
the Advise process, nurses inform pregnant women about the risks of 
smoking in general and in relation to their pregnancy, including the 
increased instance of preterm labor and birth associated with smoking. 
AWHONN also participates in the National Partnership to Help Smokers 
Quit and is part of the group focused on offering help through the 
healthcare system. We are pleased with the inclusion of emphasis on 
smoking cessation and counseling program establishment in the PREEMIE 
Act. Passage of this legislation will support more research to decrease 
the rate of smoking in pregnant women.
    Despite the limited funding the National Institute of Nursing 
Research (NINR) obtains annually, significant strides have been made to 
increase care for premature infants and their families. Nurse 
researchers supported by the NINR have examined many aspects of 
prematurity and the delivery of care in the NICU. This research has 
directly improved the care and outcomes of preterm infants. It is our 
hope that NIH funding opportunities for the PREEMIE legislation will 
include and intensify the excellent work that the NINR has done to 
date. The following are results published by NINR-funded investigators 
within the last 3 years:
     Karen A. Thomas, Ph.D., RN, found that preterm infants are 
sensitive to changes in their thermal environment, and caregiving 
activities may cause unintentional thermal alterations. Nursing care 
has changed in order to guard these infants from environmental factors 
and procedures that might result in drops in body temperature and 
contribute to newborn morbidity.
     A nurse researcher, Debra Brandon, Ph.D., RN, CCNS, found 
that maintaining cycled light patterns in the NICU benefits preterm 
infant growth, and may facilitate retinal development.
     Sandra Weiss, Ph.D., DNSc, RN, FAAN, found that low birth 
weight infants are susceptible to over-stimulation from parental touch, 
making them at-risk for long-term attachment problems.
     Gail McCain, RN, Ph.D. used a semi-demand, ad lib feeding 
protocol to help establish earlier full oral feedings in premature 
infants. This feeding method has helped these very small NICU babies 
experience normal oral feeding earlier and more successfully. In the 
long run, this helps these infants gain and maintain their weight.
     Suzanne Thoyre, RN, Ph.D. showed that, even nearing 
discharge, preterm infants can experience breathing difficulties while 
feeding. This important research has helped prepare nurses and parents 
to assess newborns and use different strategies to decrease risks and 
consequences associated with breathing difficulties.
     By observing NICU staff, Elaine Larson, RN, Ph.D., FAAN, 
CIC, found that many NICU nurses and physicians demonstrate suboptimal 
adherence to hand hygiene protocols. This has lead to an increase in 
attention to hand washing in order to decrease hospital acquired 
infection.
    The results of these studies provide neonatal nurses, 
practitioners, and other caretakers with new knowledge to address the 
care of the infant and the family, improve the health and development 
of preterm and other sick infants, and provide optimal discharge 
planning and follow-up care to at-risk infants and their families.
    Finally, also included within the study would be the establishment 
of Neonatal Intensive Care Unit (NICU) family support programs with an 
emphasis on staff professional development and the promotion of family-
centered care. It is in the NICU that families with a preterm infant 
often experience their darkest hours, and nurses are there with these 
families throughout the process. It is important, as shown in the 
preceding section, that families receive the support they desperately 
need while their infant is cared for in the NICU. AWHONN believes that 
the promotion of parenting and family-centered care is a critical part 
of comprehensive services to preterm infants and their families in the 
NICU. Nurses play an essential role in enhancing parenting and family-
centered care in the NICU. This legislation will help foster a 
relationship where parents partner with health care providers to care 
for preterm infants, provide support for families and professionals 
responsible for caring for NICU patients, and ultimately improve the 
outcome for these children.
    As an organization representing thousands of nurses who are on the 
frontline caring for pregnant women and newborns, AWHONN is pleased to 
lend its support to this crucial legislation. AWHONN's nurse members 
have long played a critical role in helping new mothers avoid pre-term 
labor, and provide emotional support and caring for premature babies. 
We look forward to playing a key role in the reduction of premature 
births and to bring healthier, full-term babies into the world. Because 
half of all preterm births have no identifiable underlying etiology, 
and many of the known contributors to preterm labor and birth risk have 
only an indirect-causal relationship, the need for more research to 
better understand this problem is critical.
    The Congress must act now and act quickly to pass the PREEMIE Act 
and reduce the number of children and parents who suffer not only 
physically, but also emotionally, because of premature birth.
    Thank you for the opportunity to submit testimony on this crucial 
area of maternal-child health.

        Prepared Statement Of The American Hospital Association

    Today, one in eight babies are born prematurely in the U.S. This is 
a statistic many hospital caregivers know all too well. Day in and day 
out, hospitals and their dedicated neonatal intensive care unit (NICU) 
staff face the medical and emotional challenges of caring for these 
babies fighting to survive.
    The number of premature babies has been rising for more than 20 
years making it essential we find answers as to the cause of premature 
birth. In nearly half the cases of premature birth, the causes are 
unknown. If we are to turn the tide, researchers and medical staff must 
be focused and be adequately funded.
    That's why the American Hospital Association strongly supports this 
legislation. It will go a long way to expand, intensify and coordinate 
research related to premature births--all with the goal of healthier 
babies and families.

    Prepared Statement Of The American College Of Obstetricians And 
                             Gynecologists

    The American College of Obstetricians and Gynecologists (ACOG), on 
behalf of its 46,000 partners in women's health care, is pleased to 
offer this statement to the Senate Committee on Health, Education, 
Labor, and Pensions, Subcommittee on Children and Families. We thank 
Chairman Alexander, Ranking Member Dodd, and the entire subcommittee 
for their leadership to support increased research, education and 
prevention efforts to decrease prematurity.
    ACOG Fellows care for and treat women of all ages. We believe 
improving maternal and child health is a vital investment, particularly 
in a woman's childbearing years. A mother's health is a strong 
predictor of child's life-long health and well-being.

ACOG Partner in Prematurity Campaign

    ACOG is one of three major partners in the March of Dimes 
Prematurity Campaign, a 5-year effort to raise awareness about and 
reduce the rate of pre-term delivery. The Campaign aims to both 
increase awareness of the severity of prematurity, and decrease the 
rate of pre-term birth by 15 percent. Along with the American Academy 
of Pediatrics (AAP), and the Association of Women's Health Obstetric 
and Neonatal Nurses (AWHONN), ACOG will work to ensure that providers 
have the latest information available on the known risks of pre-term 
birth.
    The cause of approximately half of all premature births is unknown. 
Studies have cited a history of tobacco use, maternal psychological 
stress, and periodontal disease as possible causes of prematurity, and 
studies have contradicted the commonly held belief that home uterine 
activity monitoring reduces the frequency of pre-term birth. ACOG 
policy now supports the use of progesterone as a possible treatment for 
women who have a history of pre-term labor.
    Although the causes are largely unknown, pre-term labor and 
delivery have lasting health effects on both the mother and child, and 
disproportionately affect high-risk ethnic groups. Premature babies who 
survive may suffer lifelong consequences, including chronic lung 
disease, and vision and hearing loss. African-American mothers show the 
highest rate of pre-term labor at 17 percent, and low birth weight is 
the leading cause of death for African-American infants.
    ACOG supports the Prematurity Research Expansion and Education for 
Mothers who deliver Infants Early Act, or PREEMIE Act, introduced by 
Senators Lamar Alexander (R-TN) and Christopher Dodd (D-CT), which 
builds upon and supports the significant research and outreach 
currently conducted by the National Institute of Child Health and Human 
Development (NICHD) and the Centers for Disease Control and Prevention 
(CDC). The bill focuses on pre-term labor and delivery research, 
provider education and support, and the health and economic costs of 
prematurity.
    The NICHD's Maternal Fetal Medicine Unit Network (MFMU) focuses on 
clinical questions in maternal fetal medicine and obstetrics, 
particularly with respect to pre-term birth. The current Network is 
comprised of 14 university-based clinical centers and a data-
coordinating center where more than 24 clinical trials, cohort studies 
and registries have been completed or are in progress. The NICHD has 
been instrumental in identifying progesterone as a possible method of 
reducing the incidence of pre-term labor.
    These efforts are complimented by the Centers for Disease Control 
and Prevention (CDC) prematurity reduction efforts, which target 
surveillance, epidemiological research and State capacity building. The 
Centers collect vital data such as the mother's education and health, 
and history of tobacco use, but need more flexible technology systems 
to monitor this data. The CDC also partners with 31 State health 
agencies to promote healthy pregnancies, but due to lack of funds, has 
not been able to provide assistance to 13 additional States.
    In addition to the research conducted through the NICHD and the 
CDC, physician education and access to care are essential components to 
reducing pre-term labor. By educating women's health care providers on 
the latest prematurity research findings, providers can offer timely 
and appropriate care to women. Increasing women's access to mental 
health and smoking cessation counseling, two suspected risk factors for 
pre-term labor, can also help providers reduce prematurity by improving 
maternal health.
    The economic and health-related burden prematurity places on the 
health care system is immeasurable. A key provision in the PREEMIE Act 
calls for a joint CDC and NIH report on the effectiveness of outreach 
programs. The report will seek to examine short and long-term 
disabilities associated with premature births and the impact on 
maternal health, health care and quality of life. It will also offer 
recommendations on best practices and interventions to prevent 
premature birth, as well as the most promising areas of research to 
further prevention efforts.

Ob-Gyn Representation on NICHD Advisory Council

    The important role that NICHD plays in understanding and finding 
solutions to prematurity raises a serious related concern that we'd 
like to bring to the committee's attention.
    NICHD has overseen tremendous advancements for women including 
improving pregnancy and childbirth outcomes, and identifying cures for 
diseases and conditions affecting women of all ages and at all stages 
in life. NICHD is, in fact, the Institute where the vast majority of 
ob-gyn related research takes place and the only Institute where ob-
gyns have a prominent role. It's critical, then, to require that the 
NICHD Advisory Council include an adequate number of individuals who 
have distinguished themselves in ob-gyn clinical practice and research.
    Currently, this important Council, which guides the Institute's 
research funding decisions, is composed of 17 appointed members, 
including pediatricians, ob-gyns, sociologists, biologists, media 
consultants, and nurses. Currently, the Council includes 3 
distinguished ob-gyns, who bring to the Council years of expertise and 
knowledge of women's health care needs, research priorities, and the 
impact of research discoveries on women's lives. One of these 
individual's terms expires in November 2004, giving NICHD the 
opportunity to appoint another individual to fill this slot.
    ACOG worked actively with the NICHD to advocate the appointment of 
another ob-gyn to this position, and we are deeply troubled by 
indications that NICHD plans to fill this position with an attorney, 
rather than with another ob-gyn. Research conducted at NICHD helps 
shape the future of women's health care. Women across America and the 
world suffer from issues of maternal morbidity, uterine fibroids, 
vulvodynia and numerous other health care issues that are far from 
being understood and cured. The world faces global challenges, too, of 
the spread of sexually transmitted diseases, which have barely been 
acknowledged, much less challenged and defeated.
    The NICHD Advisory Council must include an adequate number of ob-
gyns who are experts in these clinical and research areas. We object 
strongly to any attempt to reduce the ability of our specialty to 
contribute to the research direction of this Institute which is 
obviously so critical to the area that we know better than any other 
group or medical specialty--women's health.
    We look to Congress to amend the NICHD statute to require that its 
Advisory Council include no fewer than three experts in the field of 
ob-gyn. This action is necessary to ensure that decisions that will 
affect the future of women's health care are made by individuals with 
expertise and a deep level of commitment to the field. We hope to work 
actively with this committee and the Congress to restructure the 
Council representation requirements.

Medical Liability Crisis Puts Moms and Babies At Risk

    The dwindling numbers of practicing obstetrician-gynecologists 
further jeopardizes the high rates of pre term labor. Across the 
country, liability insurance for obstetrician-gynecologists has become 
prohibitively expensive. Premiums have tripled and quadrupled 
practically overnight. In some areas, ob-gyns can no longer obtain 
liability insurance at all, as insurance companies fold or abruptly 
stop insuring doctors.
    When ob-gyns cannot find or afford liability insurance, they are 
forced to stop delivering babies, curtail surgical services, or close 
their doors. The shortage of care affects hospitals, public health 
clinics, and medical facilities in rural areas, inner cities, and 
communities across the country. The medical liability crisis affects 
every aspect of our Nation's ability to deliver health care services, 
harming our patients most, who lose access to care they deserve.
    When confronted with substantially higher costs for liability 
coverage or the reality of not being able to find coverage at any 
price, ob-gyns and other women's health care professionals stop 
delivering babies, reduce the number they do deliver, and further cut 
back--or eliminate--care for high-risk mothers. With fewer women's 
health care professionals, access to early prenatal care is reduced, 
depriving women of the proven benefits of early intervention.
    Women in underserved rural areas have historically been 
particularly hard hit by the loss of physicians and other women's 
health care professionals, as increases in liability insurance costs 
are forcing rural providers to stop delivering babies and pregnant 
women to drive long distances for prenatal and delivery care.
    This crisis also means that community clinics must cutback 
services, jeopardizing the Nation's 39 million uninsured patients--the 
majority of them women and children--who rely on community clinics for 
health care. Unable to shift higher insurance costs to their patients, 
these clinics have no alternative but to care for fewer people. Low-
income pregnant women lose critical prenatal care as a result.
    It is clear that Congress must end the medical liability crisis or 
women will be at greater risk for losing care.
    We thank the committee for addressing this important issue of 
prematurity. Both the NICHD and the CDC have made significant strides 
in reducing prematurity, but there is still no cure. We look forward to 
working with the committee and the Congress to guarantee adequate ob-
gyn leadership at NICHD and to enact meaningful medical liability 
reform. And we will work with Congress and the Administration to 
support prematurity reduction and elimination through education, 
prevention and research.

     Prepared Statement of the Society for Maternal-Fetal Medicine

    Mr. Chairman and Members of the Committee, I am James Ferguson, 
President of the Society for Maternal-Fetal Medicine and Professor and 
Chair, in the Department of Obstetrics and Gynecology at the University 
of Kentucky College of Medicine. The Society for Maternal-Fetal 
Medicine appreciates the opportunity to submit testimony in support of 
S. 1726, the ``Prematurity Research Expansion and Education for Mothers 
who Deliver Infants Early Act'' or the ``PREEMIE Act''. We believe this 
bill provides meaningful steps in educating pregnant women about the 
problems of prematurity; expanding research to identify the causes of 
preterm labor and prematurity; and promoting the delivery of improved 
perinatal care.
    The primary objectives of the Society for Maternal-Fetal Medicine 
is to promote and expand education in maternal-fetal medicine and to 
encourage the exchange of new ideas and research concerning the most 
recent approaches and treatments for obstetrical problems. Our Society 
has a very strong interest in improving pregnancy outcome through 
basic, translational and clinical research and through education 
leading to improvements in patient care.
    Maternal-Fetal Medicine subspecialists pursue an additional 2 to 3 
years of fellowship training following completion of their 4-year 
residency program in Obstetrics and Gynecology. Maternal-Fetal Medicine 
subspecialists provide consultative services to obstetricians and other 
healthcare providers, while in other cases we assume direct care 
responsibility for the special problems that high-risk mothers and 
high-risk unborn children face. The special problems faced by these 
mothers may lead to death, short-term or in some cases, life-long 
problems for themselves and/or their babies.
    Preterm birth stands out as a major obstetrical challenge in the 
U.S. Fetal death occurs in nearly 1 percent and neonatal mortality in 
0.5 percent of all U.S. pregnancies, and is up to 10 times greater in 
many developing countries. Yet, to date there has been little success 
in reducing the incidence of preterm births.
    S. 1726 would authorize the National Institutes of Health (NIH) and 
the Centers for Disease Control and Prevention (CDC) to expand research 
related to preterm labor and delivery and the care and treatment, and 
outcomes of preterm and low birthweight infants. For example:
    Expansion of research in this area within the National Institutes 
of Health would allow the National Institute of Child Health and Human 
Development (NICHD) to undertake major initiatives to hasten a better 
understanding of the pathophysiology of premature birth, discover novel 
diagnostic biomarkers, and ultimately aid in formulating more effective 
intervention strategies to prevent premature birth. We believe that the 
next major advance in elucidating the etiology of preterm delivery 
involves understanding the mechanism through the evaluation of protein 
and gene expression. These techniques are widely used in other medical 
fields and it is imperative they are used to understand prematurity.
    In addition, the NICHD Maternal-Fetal Medicine Unit (MFMU) Network 
conducts large prospective clinical trials to address issues such as 
preterm birth. Since its establishment in 1986, this 14-center body has 
proven itself to be the most effective and cost efficient means to 
conduct the types of large-scale clinical trials needed for maternal-
fetal research. Recently, the MFMU Network announced the results of the 
Progesterone Trial, a clinical research study that showed that 
treatment with progesterone could substantially reduce the incidence of 
preterm birth in high-risk pregnancies. This is one of the first 
advances in this area, despite extensive efforts over decades.
    Research by the MFMU Network has helped women and their babies by 
finding the best courses of treatment and prevention for high-risk 
pregnancies. S. 1726 would provide a secure source of funding that 
would enable the MFMU Network to continue to launch new studies and to 
build on existing studies.
    The Centers for Disease Control and Prevention (CDC) and State 
health departments currently use a pregnancy risk assessment monitoring 
system (PRAMS) to collect state-specific, population-based data on 
maternal attitudes and experiences before, during and immediately after 
pregnancy. The data can be used to identify groups of women at high 
risk for pregnancy complications, to monitor changes in the health 
status of the mother and baby, and to measure progress in improving the 
health of mothers and infants.
    An intensified effort within the CDC could provide for expansion of 
the PRAMS to include establishing a uniform State and national 
reporting system of pregnancy related complications to track 
interventions and patterns of care received, and to conduct research 
into the causes of and interventions for pregnancy complications, 
especially complications relating to outcome disparities in different 
racial and ethnic populations.
    The bill also provides for public and provider education and 
support services. It is crucial that the scientific knowledge that has 
been obtained be disseminated to health professionals and providers, as 
well as to the public so that the best treatment and preventive 
strategies are available to the mother and infant.
    Our Society is also supportive of an interagency committee focusing 
on prematurity and low birthweight that will provide a forum for 
sharing information and will facilitate the development of 
collaborative research activities.
    Mr. Chairman, we applaud your commitment to reduce the incidence of 
prematurity. It is a problem that merits research emphasis and 
increased resources. The Society for Maternal Fetal Medicine is honored 
to lend its support to S. 1726.

                     Questions of Senator Jeffords

    A recent brief by the Children's Dental Health Project stated that 
``A growing body of research supports an association between 
periodontal disease (inflammatory gum disease) and unfavorable birth 
outcomes associated with PLBW.''
    Question 1. How is the NIH working to determine if this association 
is causal?
    Question 2. How is NICHD working with NIDCR to improve the evidence 
base on this possible link?
    Question 3. How is the CDC utilizing its Pregnancy Risk Assessment 
Monitoring System (PRAMS) to determine the extent of this association 
and the oral health status of all pregnant women? 




    [Whereupon, at 12:02 p.m., the subcommittee was adjourned.]

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