NIH Consensus Development Conference on Inhaled Nitric Oxide Therapy for Premature Infants, 43535 [2010-18216]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 142 / Monday, July 26, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
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 longterm 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
VerDate Mar<15>2010
16:04 Jul 23, 2010
Jkt 220001
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
43535
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
consensus@mail.nih.gov. 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
https://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 https://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
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form N–644, Revision of a
Currently Approved Information
Collection; Comment Request
30-Day notice of information
collection under review: Form N–644,
Application for Posthumous
Citizenship; OMB Control No. 1615–
0059.
ACTION:
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. This information collection was
previously published in the Federal
Register on April 22, 2010, at 75 FR
21013, allowing for a 60-day public
comment period. The 60-day notice
mentioned that during the 60-day
comment period USCIS would be
evaluating whether to revise the Form
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Notices]
[Page 43535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18216]
[[Page 43535]]
-----------------------------------------------------------------------
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 consensus@mail.nih.gov. 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 https://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 https://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
