[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Notices]
[Page 43535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18216]



[[Page 43535]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


NIH Consensus Development Conference on Inhaled Nitric Oxide 
Therapy for Premature Infants

Notice

    Notice is hereby given of the National Institutes of Health (NIH) 
``NIH Consensus Development Conference on Inhaled Nitric Oxide Therapy 
for Premature Infants'' to be held October 27-29, 2010, in the NIH 
Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. 
The conference will begin at 8:30 a.m. on October 27 and 28, and at 9 
a.m. on October 29, and will be open to the public.
    Infants born before the 37th week of pregnancy are said to be 
``premature'' or ``preterm'' and face increased risk for a variety of 
complications. Babies born before the 28th week of pregnancy--more than 
30,000 per year in the United States--are particularly vulnerable to 
breathing problems such as respiratory distress syndrome and 
respiratory failure due to their underdeveloped lungs. These infants 
often need respiratory support in the first days and weeks after birth. 
Those premature infants who still require supplemental oxygen 36 weeks 
after conception are diagnosed with bronchopulmonary dysplasia, which 
places them at greater risk for death or problems with long-term lung 
health, brain development, and brain function.
    Nitric oxide is a chemical compound in gas form that is sometimes 
used to treat infants with severe breathing problems. Inhaled nitric 
oxide therapy was approved by the U.S. Food and Drug Administration in 
2000 to treat term and near-term infants (born after the 33rd week of 
pregnancy) with respiratory failure. Inhaled nitric oxide therapy is 
typically administered in the neonatal intensive care unit using a 
device that delivers the drug in constant concentrations. It acts as a 
pulmonary vasodilator, widening the opening of blood vessels in the 
lungs. In term and near-term infants, use of this therapy may shorten 
the length of time respiratory support is required, thereby reducing 
progression to bronchopulmonary dysplasia and improving long-term lung 
health and brain development and function.
    Since its approval, researchers have examined expanding the use of 
inhaled nitric oxide therapy to treat premature babies born at less 
than 34 weeks' gestation. Studies to evaluate its safety and efficacy 
for these infants have had mixed results in terms of key outcomes. 
Thus, the potential benefits and harms of its use for premature infants 
with varying degrees of respiratory illness are not completely 
understood.
    To advance understanding of these important issues, the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development and the Office of Medical Applications of Research of the 
NIH will convene a Consensus Development Conference from October 27-29, 
2010. The conference will address the following key questions:
     Does inhaled nitric oxide therapy increase survival and/or 
reduce the occurrence or severity of bronchopulmonary dysplasia among 
premature infants who receive respiratory support?
     Are there short-term risks of inhaled nitric oxide therapy 
among premature infants who receive respiratory support?
     Are there effects of inhaled nitric oxide therapy on long-
term pulmonary and/or neurodevelopmental outcomes among premature 
infants who receive respiratory support?
     Does the effect of inhaled nitric oxide therapy on 
bronchopulmonary dysplasia and/or death or neurodevelopmental 
impairment vary across subpopulations of premature infants?
     Does the effect of inhaled nitric oxide therapy on 
bronchopulmonary dysplasia and/or death or neurodevelopmental 
impairment vary by timing of initiation, mode of delivery, dose and 
duration, or concurrent therapies?
     What are the future research directions needed to better 
understand the risks, benefits, and alternatives to nitric oxide 
therapy for premature infants who receive respiratory support?
    An impartial, independent panel will be charged with reviewing the 
available published literature in advance of the conference, including 
a systematic literature review commissioned through the Agency for 
Healthcare Research and Quality. The first day and a half of the 
conference will consist of presentations by expert researchers and 
practitioners and open public discussions. On Friday, October 29, the 
panel will present a statement of its collective assessment of the 
evidence to answer each of the questions above. The panel will also 
hold a press telebriefing to address questions from the media. The 
draft statement will be published online later that day, and the final 
version will be released approximately six weeks later. The primary 
sponsors of this meeting are the NIH Eunice Kennedy Shriver National 
Institute of Child Health and Human Development and the NIH Office of 
Medical Applications of Research.
    Advance information about the conference and conference 
registration materials may be obtained from the NIH Consensus 
Development Program Information Center by calling 888-644-2667 or by 
sending e-mail to [email protected]. The Information Center's 
mailing address is P.O. Box 2577, Kensington, Maryland 20891. 
Registration information is also available on the NIH Consensus 
Development Program Web site at http://consensus.nih.gov.

    Please Note:  The NIH has instituted security measures to ensure 
the safety of NIH employees and property. All visitors must be 
prepared to show a photo ID upon request. Visitors may be required 
to pass through a metal detector and have bags, backpacks, or purses 
inspected or x-rayed as they enter NIH buildings. For more 
information about the security measures at NIH, please visit the Web 
site at http://www.nih.gov/about/visitorsecurity.htm.


    Dated: July 19, 2010.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2010-18216 Filed 7-23-10; 8:45 am]
BILLING CODE 4140-01-P