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112. Antenatal Corticosteroids Revisited: Repeat Courses National Institutes of Health Consensus Development Conference Statement August 17-18, 2000From: Dean G. Huffman (perinatl@slip.net)Sun Oct 8 14:50:19 2000
Readers of this forum might wish to go to the following URl: http://odp.od.nih.gov/consensus/cons/112/112_statement.htm - - - Essentially what it says is: 112. Antenatal Corticosteroids Revisited: Repeat Courses National Institutes of Health Consensus Development Conference Statement August 17-18, 2000 This statement was originally published as: Antenatal Corticosteroids Revisited: Repeat Courses. NIH Consens Statement 2000 August 17-18; 17(2): 1-10. For making bibliographic reference to consensus statement no. 112 in the electronic form displayed here, it is recommended that the following format be used: Antenatal Corticosteroids Revisited: Repeat Courses. NIH Consens Statement Online 2000 August 17-18; [cited year, month, day]; 17(2): 1-10. NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. Introduction 1. Is the evidence on benefits and risks of repeat courses of antenatal corticosteroids sufficient to permit consensus recommendations? 2. If so, what are the recommendations? 3. If not, what additional information should be obtained? Conclusions Consensus Development Panel Speakers Planning Committee Conference Sponsors Conference Cosponsors Introduction Preterm delivery remains a major cause of illness and death in infants. Corticosteroid treatment of pregnant women who deliver prematurely was first introduced in 1972 to enhance fetal lung maturity. Subsequent research focused on the ability of corticosteroids to reduce mortality and brain injury in preterm neonates. In 1994, the National Institutes of Health sponsored a Consensus Development Conference on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes to assess the effectiveness of antenatal corticosteroid therapy. The consensus panel concluded that giving a single course of corticosteroids to pregnant women at risk for preterm delivery reduces the risk of death, respiratory distress syndrome, and intraventricular hemorrhage in their preterm infants. The 1994 panel noted that optimal benefit of antenatal corticosteroid therapy lasts 7 days. The panel also noted that the potential benefits and risks of repeated administration of antenatal corticosteroids 7 days after the initial course are unknown and called for additional research on this issue. However, during recent years the use of repeat courses of antenatal corticosteroids has become widespread in the United States, England, and Australia. Such courses include weekly dosages, occasional dosages, or rescue therapy (single-course steroids) given on an as-needed basis for planned or imminent delivery. The NIH organized this 1? day conference to present research on repeat courses of antenatal corticosteroid therapy. After a day of presentations and audience discussion, an independent, non-Federal consensus development panel weighed the scientific evidence and wrote a draft statement that was presented to the audience on the second day. The consensus statement addressed these three questions: 1.Is the evidence on benefits and risks of repeat courses of antenatal corticosteroids sufficient to permit consensus recommendations? 2.If so, what are the recommendations? 3.If not, what additional information should be obtained? The primary sponsors of this meeting were the National Institute of Child Health and Human Development and the NIH Office of Medical Applications of Research. The National Institute of Nursing Research and the National Heart, Lung, and Blood Institute were co-sponsors. 1. Is the evidence on benefits and risks of repeat courses of antenatal corticosteroids sufficient to permit consensus recommendations? Studies of single versus repeat courses of antenatal corticosteroids were evaluated for benefits and risks through a review of published literature and data presented during the consensus conference. Benefits In preterm animals, multiple doses of antenatal corticosteroids improve lung function when compared with a single dose. These benefits include improved lung mechanics and gas exchange as well as increased lung volume and surfactant pools. No published data on any of the possible benefits to humans of repeat courses of antenatal corticosteroids were available from randomized controlled trials, and the data from nonrandomized controlled trials were limited in quality. Many studies were published as abstracts. The most common research design was a retrospective evaluation of clinical data; other studies were retrospective cohort comparisons. Methodologic inconsistencies, such as variation in latent period from last dose to delivery, in number of repeat courses compared, and variability of inclusion of multifetal pregnancies made it difficult to combine data from multiple studies. Despite their limitations, these studies suggested possible benefits in reduction of the incidence and severity of respiratory distress syndrome, and reduction in the incidence of patent ductus arteriosus. There is little or no evidence to support other possible benefits, including a reduction in mortality rate or reductions in the incidence of intraventricular hemorrhage, chronic lung disease, sepsis, necrotizing enterocolitis, or retinopathy of prematurity. Risks Data from studies on both animals and humans raise questions about the safety of repeat doses of antenatal corticosteroids. Animal studies have shown that repeat courses of antenatal corticosteroids have deleterious effects on lung growth and organization, cerebral myelination, the function of the hypothalamic-pituitary-adrenal axis, and retinal development. In addition, there is evidence for a dose dependent effect on fetal growth and persistence of immature lung architecture. Evidence from human studies on both the short and long-term adverse effects of repeat doses of corticosteroids is contradictory and therefore inconclusive. The available human data come from inadequately controlled observational and retrospective studies, some of which suggest adverse maternal and fetal effects. Even when studies suggest a deleterious outcome, they are generally inconsistent. In addition, none of the studies controlled for postnatal corticosteroid treatment, used widely at the time of the reports available to the panel. The study populations often excluded children whose mothers had received repeat courses of corticosteroids and who delivered late in the preterm period or at term. Nevertheless, some studies suggest matters of concern. For the mother, these include increased maternal infection and suppression of the maternal hypothalamic-pituitary-adrenal axis. Fetal/neonatal effects include decreased somatic and brain growth, adrenal suppression, neonatal sepsis, chronic lung disease, and mortality. No consistent effect on intraventricular hemorrhage was apparent from the available data. Although no increase in the incidence of cerebral palsy was noted, neurodevelopmental followup studies suggest an increase in psychomotor delay and behavioral problems. Concern about the effects of repeated corticosteroids on the central nervous system is heightened by the fact that randomized controlled trials of postnatal corticosteroids have found adverse neurologic effects in infants of gestational age similar to those treated in utero. Summary Data from currently available studies assessing benefits and risks are inadequate to argue for or against the use of repeat or rescue courses of antenatal corticosteroids for fetal maturation. 2. If so, what are the recommendations? Clinical Recommendations - All pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days should be considered candidates for antenatal treatment with a single course of corticosteroids. - Treatment consists of two doses of 12 mg of betamethasone given intramuscularly 24 hours apart or four doses of 6 mg of dexamethasone given intramuscularly 12 hours apart, as recommended by the consensus panel in 1994. There is no proof of efficacy for any other regimen. - Because of insufficient scientific data from randomized clinical trials regarding efficacy and safety, repeat courses of corticosteroids should not be used routinely. In general, it should be reserved for patients enrolled in randomized controlled trials. Several randomized trials are in progress. 3. If not, what additional information should be obtained? The following research is recommended: - Well-designed randomized clinical trials which are of sufficient power to evaluate efficacy and safety are needed. - In light of the possible risks, the design of randomized clinical trials should minimize the exposure of mothers and fetuses while protecting the integrity of the research design. These trials should assess: - Clinically important neonatal morbidities, such as respiratory distress syndrome, chronic lung disease, and brain injury. - Clinically important maternal morbidities, such as infection and adrenal suppression. - The effects of repeat courses of corticosteroids on patterns of fetal and postnatal growth. - The potential effects of incremental courses on benefits and risks, since the benefits of repeat courses of antenatal corticosteroids are likely to decrease with advancing gestational age. - The efficacy and safety of rescue therapy. - The interaction of repeat courses of antenatal corticosteroids with postnatal corticosteroid therapy. - Long-term growth and neuropsychological outcome up to at least school age, using state-of-the-art techniques. In addition: - Animal studies should evaluate the pathophysiologic and metabolic mechanisms of potential benefits and risks, including the effects of repeat corticosteroids on central nervous system myelination and brain development. Conclusions - The collective international data continue to support unequivocally the use and efficacy of a single course of antenatal corticosteroids using the dosage and interval of administration specified in the 1994 Consensus Development Conference report. - The current benefit and risk data are insufficient to support routine use of repeat or rescue courses of antenatal corticosteroids in clinical practice. - Clinical trials are in progress to assess potential benefits and risks of various regimens of repeat courses. Until data establish a favorable benefit-to-risk ratio, repeat courses of antenatal corticosteroids, including rescue therapy, should be reserved for patients enrolled in clinical trials. Consensus Development Panel Larry C. Gilstrap III, M.D. Panel and Conference Chairperson Emma Sue Hightower Chairman and Professor Department of Obstetrics, Gynecology, and Reproductive Sciences University of Texas-Houston Medical School Houston, Texas William H. Clewell, M.D. Associate Director Department of Maternal-Fetal Medicine Good Samaritan Regional Medical Center Phoenix, Arizona Mary E. D'Alton, M.D. Virgil G. Damon Professor of Obstetrics and Gynecology Director, Division of Maternal-Fetal Medicine Columbia University College of Physicians and Surgeons New York Presbyterian Hospital New York, New York Marilyn B. Escobedo, M.D. Professor, Department of Pediatrics, Division of Neonatology Medical Director, University Hospital Newborn Intensive Care Unit University of Texas Health Science Center at San Antonio San Antonio, Texas Joel Frader, M.D. Professor of Pediatrics Program in Medical Ethics and Humanities Northwestern University Medical School Attending Physician Co-Director, Hospice and Palliative Care Program Chair, Institutional Review Board Children's Memorial Hospital Chicago, Illinois Dwenda K. Gjerdingen, M.D. Associate Professor Department of Family Practice and Community Health University of Minnesota Medical School St. Paul, Minnesota Jan Goddard-Finegold, M.D. Associate Professor of Pediatrics and Pathology Division of Pediatric Neurology Baylor College of Medicine and Texas Children's Hospital Houston, Texas Robert L. Goldenberg, M.D. Charles E. Flowers Professor Department of Obstetrics and Gynecology University of Alabama School of Medicine Birmingham, Alabama Maureen Hack, MBChB Professor of Pediatrics and Reproductive Biology Rainbow Babies and Children's Hospital of University Hospitals of Cleveland Case Western Reserve University Cleveland, Ohio Thomas N. Hansen, M.D. Chairman, Department of Pediatrics Ohio State University Chief Executive Officer Children's Hospital Columbus, Ohio Ralph E. Kauffman, M.D. Marion Merrell Dow/Missouri Chair in Medical Research Professor of Pediatrics and Pharmacology University of Missouri-Kansas City Children's Mercy Hospital Kansas City, Missour Emmett B. Keeler, Ph.D. Senior Mathematician Health Program The RAND Graduate School Santa Monica, California William Oh, M.D. Sylvia Kay Hassenfeld Professor of Pediatrics Chairman, Department of Pediatrics Brown University School of Medicine Pediatrician-in-Chief, Rhode Island Hospital Medical Director, Hasbro Children's Hospital Providence, Rhode Island E. Albert Reece, M.D. Abraham Roth Professor and Chairman Department of Obstetrics, Gynecology, and Reproductive Sciences Temple University School of Medicine Philadelphia, Pennsylvania Elizabeth J. Susman, Ph.D., R.N. Jean Phillips Shibley Professor Department of Biobehavioral Health Pennsylvania State University University Park, Pennsylvania Marlyn G. Vogel, Ed.D. Licensed Psychologist Limekiln Simmons Special Services School District of Hatboro-Horsham Ambler, Pennsylvania Speakers Beverly Banks, M.D., Ph.D. Neonatologist Division of Neonatology Children's Hospital of Philadelphia Philadelphia, Pennsylvania M. Sean Esplin, M.D. Assistant Professor Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology University of Utah Health Sciences Center Salt Lake City, Utah Noel French, MBChB, FRACP Head of Neonatal Followup King Edward Memorial Hospital Subiaco, Perth Australia Debra Guinn, M.D. Assistant Professor Department of Obstetrics and Gynecology University of Colorado Health Sciences Center and Denver Health Medical Center Denver, Colorado Alan Jobe, M.D., Ph.D. Professor of Pediatrics Children's Hospital Medical Center of Cincinnati Cincinnati, Ohio Brian Mercer, M.D. Director Maternal-Fetal Medicine Department of Obstetrics and Gynecology MetroHealth Medical Center Cleveland, Ohio Kellie E. Murphy, M.D., M.Sc., FRCSC Assistant Professor University of Toronto Department of Obstetrics and Gynecology Mount Sinai Hospital Toronto, Ontario Canada James F. Padbury, M.D. Professor and Vice Chairman Department of Pediatrics Brown University School of Medicine Pediatrician-in-Chief Women and Infants Hospital of Rhode Island Providence, Rhode Island James R. Scott, M.D. Professor Department of Obstetrics and Gynecology University of Utah Health Sciences Center Salt Lake City, Utah John C. Sinclair, M.D. Professor Department of Pediatrics McMaster University Medical Center Hamilton, Ontario Canada Michael Socol, M.D. Vice Chair and Professor Head, Section of Maternal-Fetal Medicine Department of Obstetrics and Gynecology Northwestern University Medical School Chicago, Illinois Ronald J. Wapner, M.D. Director Division of Maternal-Fetal Medicine Thomas Jefferson University Hospital Philadelphia, Pennsylvania Robert M. Ward, M.D., FAAP, F.C.P. Professor Director, Pediatric Pharmacology Program Department of Pediatrics University of Utah School of Medicine Salt Lake City, Utah Planning Committee Duane Alexander, M.D. Planning Committee Chairperson Director National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland John A. Bowersox Communications Specialist Office of Medical Applications of Research Office of the Director National Institutes of Health Bethesda, Maryland Jerry M. Elliott Program Analysis and Management Officer Office of Medical Applications of Research Office of the Director National Institutes of Health Bethesda, Maryland Barnett S. Kramer, M.D., M.P.H. Director Office of Medical Applications of Research Office of the Director National Institutes of Health Bethesda, Maryland Catherine Y. Spong, M.D. Pregnancy and Perinatology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Judith M. Whalen, M.P.A. Associate Director for Science Policy, Analysis, and Communication National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Linda Wright, M.D. Special Assistant to the Director Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland Conference Sponsors National Institute of Child Health and Human Development Duane Alexander, M.D. Director Office of Medical Applications of Research Barnett S. Kramer, M.D., M.P.H. Director Conference Cosponsors National Institute of Nursing Research Patricia A. Grady, Ph.D., R.N., F.A.A.N. Director National Heart, Lung, and Blood Institute Mary Anne Berberich, Ph.D. Scientific Research Group Leader
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