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:
- 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?
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.
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
of the National Institutes of Health
Partners
The Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention provided additional conference development support.
Wednesday, October 27, 2010
| 8:30 a.m. | Opening Remarks Director |
| 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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