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Inhaled Nitric Oxide Therapy for Premature Infants - artwork


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

October 27-29, 2010
Bethesda, Maryland

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Background

 

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, 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 better understand the benefits and risks of inhaled nitric oxide therapy for premature infants, the National Institutes of Health will convene a Consensus Development Conference October 27-29, 2010, to assess the available scientific evidence related to the following questions:



The conference is presented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Office of Medical Applications of Research, with additional support from the National Heart, Lung, and Blood Institute. Invited experts will present scientific evidence pertinent to the posed questions and a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality will be summarized. Conference attendees will have opportunities to ask questions and provide comments during open discussion periods. After weighing the scientific evidence, an unbiased, independent panel will prepare and present a consensus statement addressing the key conference questions.

Sponsors

 

Eunice Kennedy Shriver National Institute of Child Health and Human Development logo          Consensus Development Program logo

Eunice Kennedy Shriver National Institute of Child Health and Human Development
Office of Medical Applications of Research
of the National Institutes of Health

Co-Sponsor

National Heart Lung and Blood Institute logo
National Heart, Lung, and Blood Institute
of the National Institutes of Health

Partners

Agency for Healthcare Research and Quality logo          Centers for Disease Control and Prevention logo

The Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention provided additional conference development support.

Agenda

 

Wednesday, October 27, 2010

8:30 a.m.

Opening Remarks
Alan E. Guttmacher, M.D.

Director
Eunice Kennedy Shriver National Institute of Child Health
and Human Development
National Institutes of Health

8:40 a.m. Charge to the Panel
Jennifer M. Croswell, M.D., M.P.H.
Acting Director
Office of Medical Applications of Research
Office of the Director
National Institutes of Health
8:50 a.m. Conference Overview and Panel Activities
F. Sessions Cole, M.D.
Panel and Conference Chairperson
Park J. White, M.D. Professor of Pediatrics
Assistant Vice Chancellor for Children's Health
Vice Chairperson
Department of Pediatrics
Director
Division of Newborn Medicine
Washington University School of Medicine
Chief Medical Officer
St. Louis Children's Hospital
General Overview
9:00 a.m. Epidemiology of Bronchopulmonary Dysplasia (BPD): Burden of Disease and Current Practice
Roger F. Soll, M.D.
President
Vermont Oxford Network
Wallace Professor of Neonatology
Department of Pediatrics
University of Vermont College of Medicine
9:20 a.m. Biology of Bronchopulmonary Dysplasia (BPD) and Rationale for Inhaled Nitric Oxide Therapy
Philip W. Shaul, M.D.
Professor of Pediatrics
Director
Division of Pulmonary and Vascular Biology
Lowe Foundation Professor of Pediatric Critical Care Research
Department of Pediatrics
University of Texas Southwestern Medical Center at Dallas
9:40 a.m. Discussion
I. Does inhaled nitric oxide therapy increase survival and/or reduce the occurrence or severity of bronchopulmonary dysplasia (BPD) among premature infants who receive respiratory support?
  and
II. Are there short-term risks of inhaled nitric oxide therapy among premature infants who receive respiratory support?
10:00 a.m. Trial: Inhaled Nitric Oxide Therapy in Premature Infants with Respiratory Distress Syndrome
Michael D. Schreiber, M.D.
Professor and Executive Vice-Chairperson
Department of Pediatrics
University of Chicago
10:20 a.m. Inhaled Nitric Oxide for Premature Infants with Severe Respiratory Failure: Preemie Inhaled Nitric Oxide (PiNO) Trial Results
Krisa P. Van Meurs, M.D.
Professor of Pediatrics, Neonatology
Associate Chief, Clinical Programs
Division of Neonatal and Developmental Medicine
Associate Chair, Clinical Research
Department of Pediatrics
Stanford University School of Medicine
Lucile Packard Children's Hospital
10:40 a.m. Trial: Early Inhaled Nitric Oxide Therapy in Premature Newborns with Respiratory Failure
John P. Kinsella, M.D.
Professor of Pediatrics
Section of Neonatology
Medical Director
Newborn/Young Child Transport Service
Director of Clinical Research
Pediatric Heart Lung Center
Children's Hospital
University of Colorado, Denver
11:00 a.m. Discussion
11:30 a.m. Lunch
Panel Executive Session
12:30 p.m. Inhaled Nitric Oxide for Prevention of Bronchopulmonary Dysplasia (BPD)
in Premature Babies: The European Nitric Oxide (EUNO) Randomized
Controlled Trial
Jean-Christophe Mercier, M.D., M.Sci.
Professor of Pediatrics
University of Paris 7 Denis Diderot
Chief
Department of Pediatric Emergency Care
Hpital Robert-Debr
12:50 p.m. Trial: The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) Trial
Roberta A. Ballard, M.D.
Professor of Pediatrics
Division of Neonatology
Department of Pediatrics
University of California, San Francisco
Emeritus Professor of Pediatrics
University of Pennsylvania
1:10 p.m. Evidence-based Practice Center Presentation I: A Systematic Review of Inhaled Nitric Oxide Therapy in Preterm Infants: Mortality, Bronchopulmonary Dysplasia (BPD), and Short-Term Risks
Marilee C. Allen, M.D.
Professor of Pediatrics
Johns Hopkins School of Medicine
Division of Neonatology
Johns Hopkins Childrens Center
Neurodevelopmental Disabilities
Co-Director of Neonatal Intensive Care Unit Developmental Clinic
Kennedy Krieger Institute
1:30 p.m. Discussion
III. Are there effects of inhaled nitric oxide therapy on long-term pulmonary and/or neurodevelopmental outcomes among premature infants who receive respiratory support?
2:00 p.m. Neurodevelopmental Outcomes of Premature Infants
Barbara K. Schmidt, M.D., M.Sc.
Kristine Sandberg Knisely Chair in Neonatology
Department of Pediatrics
University of Pennsylvania School of Medicine
Children's Hospital of Philadelphia
2:20 p.m. Pulmonary Physiologic Outcomes Among Premature Infants
Robert S. Tepper, M.D., Ph.D.
Mary Agnes Kennedy and Kathryn Kennedy Weinberger Professor
Pediatric Pulmonary and Critical Care Section
Department of Pediatrics
Herman B. Wells Center for Pediatric Research
Indiana University School of Medicine
James Whitcomb Riley Hospital for Children
2:40 p.m. Follow-Up of Trial: Inhaled Nitric Oxide Cohort Up to 5 Years of Age
Michael D. Schreiber, M.D.
Professor and Executive Vice-Chairperson
Department of Pediatrics
University of Chicago
3:00 p.m. Neurodevelopmental Outcomes of the National Institute of Child Health and Human Development Neonatal Research Network (NRN) Trial of Inhaled Nitric Oxide for Premature Infants with Severe Respiratory Failure (Preemie Inhaled Nitric Oxide [PiNO] Trial)
Susan R. Hintz, M.D., M.S. Epi
Associate Professor of Pediatrics
Division of Neonatal Medicine and Developmental Medicine
Stanford University School of Medicine
Director
The Center for Comprehensive Fetal Health
Lucile Packard Children's Hospital
3:20 p.m. Discussion
4:00 p.m. Adjournment


Thursday, October 28, 2010

8:30 a.m. Follow-Up of Trial: Inhaled Nitric Oxide in the Prevention of Chronic Lung Disease
John P. Kinsella, M.D.
Professor of Pediatrics
Section of Neonatology
Medical Director
Newborn/Young Child Transport Service
Director of Clinical Research
Pediatric Heart Lung Center
Children's Hospital
University of Colorado, Denver
8:50 a.m. The Nitric Oxide to Prevent Chronic Lung Disease (NO CLD) Trial: Outcomes at 1 and 2 Years of Age
Michele C. Walsh, M.D., M.S.
Professor of Pediatrics
Case Western Reserve University
Medical Director
Neonatal Intensive Care Unit
Co-Chief
Division of Neonatology
Rainbow Babies & Children's Hospital
University Hospitals Case Medical Center
9:10 a.m. Inhaled Nitric Oxide for Preterm Infants: A Systematic Review
Keith J. Barrington, M.D., M.B.Ch.B.
Professor of Pediatrics
University of Montreal
Chief of Neonatology
University Hospital Center, Sainte-Justine
9:30 a.m. Evidence-based Practice Center Presentation II: Does This Therapy Influence Long-Term Pulmonary and/or Neurodevelopmental Outcomes When Used in Preterm Neonates Requiring Respiratory Support?
Elizabeth A. Cristofalo, M.D., M.P.H.
Assistant Professor of Pediatrics
Neonatal-Perinatal Medicine
Johns Hopkins Childrens Center
Johns Hopkins Hospital
9:50 a.m. Discussion
IV. Does the effect of inhaled nitric oxide therapy on bronchopulmonary dysplasia (BPD) and/or death or neurodevelopmental impairment vary across subpopulations
of premature infants?
10:30 a.m. Use and Misuse of Subgroup and Secondary Analysis in Clinical Trials
Kathleen A. Kennedy, M.D., M.P.H.
Richard W. Mithoff Professor of Pediatrics
Director
Division of Neonatal-Perinatal Medicine
Director
M.S. in Clinical Research Degree Program
University of Texas-Houston Medical School
10:50 a.m. Does the Effect of Inhaled Nitric Oxide on Bronchopulmonary Dysplasia (BPD), Death, or Neurodevelopmental Impairment Vary Across Subpopulations of Premature Infants?
Robin H. Steinhorn, M.D.
Raymond and Hazel Speck Berry Professor of Pediatrics
Vice Chair, Pediatrics
Chief
Division of Neonatology
Children's Memorial Hospital
Feinberg School of Medicine of Northwestern University
11:10 a.m. Evidence-based Practice Center Presentation III: Inhaled Nitric Oxide in Preterm Infants: A Systematic Review of Treatment in Subpopulations, and by Dosage, Timing, and Mode of Therapy Delivery
Maureen M. Gilmore, M.D.
Assistant Professor of Pediatrics
Neonatal-Perinatal Medicine
Johns Hopkins Childrens Center
Johns Hopkins Hospital
Division of Neonatology
Johns Hopkins Bayview Medical Center
11:30 a.m. Discussion
V. Does the effect of inhaled nitric oxide therapy on bronchopulmonary dysplasia (BPD) and/or death or neurodevelopmental impairment vary by timing of initiation, mode of delivery, dose and duration, or concurrent therapies?
Noon Knowns and Unknowns of Administering Inhaled Nitric Oxide
Steven H. Abman, M.D.
Professor
Department of Pediatrics
Director
Pediatric Heart Lung Center
Director
Ventilator Care Program
Co-Director
Pediatric Pulmonary Hypertension Program
University of Colorado School of Medicine
Children's Hospital
12:20 p.m. Discussion
12:30 p.m. Adjournment


Friday, October 29, 2010

9:00 a.m. Presentation of the Draft Consensus Statement
9:30 a.m. Discussion of the Draft Consensus Statement
11:00 a.m. Adjournment
Panel Meets in Executive Session
2:00 p.m. Press Telebriefing

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