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A
Data Sources and Methods

The Committee on Understanding Premature Birth and Assuring Healthy Outcomes was asked to evaluate the state of the science on the causes and consequences of preterm birth. The committee assessed the various factors contributing to preterm birth; reviewed the economic, medical, social, psychological, and educational outcomes for children and families; addressed research gaps and needs; and explored changes in health policies.

To provide a comprehensive response to the study charge, the committee examined data from a variety of sources. These data sources included a review of recent scientific literature, public input through a series of workshops, and commissioned papers on selected topics. The study was conducted over a 21-month period.

DESCRIPTION OF THE STUDY COMMITTEE

A study committee composed of 17 members was assembled to assess the available data and make recommendations. The committee membership included individuals with expertise in obstetrics and gynecology, pediatrics, environmental health, epidemiology, psychology, economics, genetics, and public health. The committee convened for six 2-day meetings in March 2005, June 2005, August 2005, October 2005, December 2005, and January 2006.



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Preterm Birth: Causes, Consequences, and Prevention A Data Sources and Methods The Committee on Understanding Premature Birth and Assuring Healthy Outcomes was asked to evaluate the state of the science on the causes and consequences of preterm birth. The committee assessed the various factors contributing to preterm birth; reviewed the economic, medical, social, psychological, and educational outcomes for children and families; addressed research gaps and needs; and explored changes in health policies. To provide a comprehensive response to the study charge, the committee examined data from a variety of sources. These data sources included a review of recent scientific literature, public input through a series of workshops, and commissioned papers on selected topics. The study was conducted over a 21-month period. DESCRIPTION OF THE STUDY COMMITTEE A study committee composed of 17 members was assembled to assess the available data and make recommendations. The committee membership included individuals with expertise in obstetrics and gynecology, pediatrics, environmental health, epidemiology, psychology, economics, genetics, and public health. The committee convened for six 2-day meetings in March 2005, June 2005, August 2005, October 2005, December 2005, and January 2006.

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Preterm Birth: Causes, Consequences, and Prevention LITERATURE REVIEW Three strategies were combined to identify literature in support of the committee’s charge. First, a search on the EMBASE and Medline databases was conducted to obtain articles from peer-reviewed journals. The searches focused on preterm birth and low birth weight, including their genetic, behavioral, biological, and environmental causes, as well as their economic, educational, health, and family consequences. Second, the reports of federal agencies, such as the National Institutes of Health and the Centers for Disease Control and Prevention, relevant to preterm birth and low birth weight were also gathered. Finally, committee members and workshop participants submitted articles and reports on those topics. The resulting database included more than 800 articles and reports. COMMISSIONED PAPERS The study committee commissioned three papers intended to provide in-depth information on selected topics, beyond the independent analysis of the literature conducted by the committee. The topics of these papers included geographic variations in rates of preterm birth, prematurity-related ethical issues, and the economic costs associated with preterm birth. The members of the committee determined the topics and the authors of the papers. These papers were not intended to serve as substitutes for the committee’s own review and analysis of the literature. The committee independently deliberated on these topics before it received the drafts of the papers. PUBLIC WORKSHOPS The committee hosted three public workshops to gain additional information on specific aspects of the study charge. These workshops were held in conjunction with the March, June, and August meetings. The study committee determined the topics and the speakers. The first workshop was intended to provide an overview of key issues in the area of preterm birth and to discuss the committee’s charge. Content focused on the biological pathways associated with preterm birth, as well as the educational, economic, and family consequences. Additionally, representatives from the study’s sponsors were invited to discuss the charge to the committee. The second workshop focused on the role of maternal conditions, such as infection, inflammation, and preeclampsia in preterm birth; the epidemiology of preterm birth; public policies that may address the problem of preterm birth; controversial issues in the care of preterm infants; and racial disparities in the rates of preterm birth. The third and final

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Preterm Birth: Causes, Consequences, and Prevention workshop focused on barriers to clinical research. Specifically, presenters addressed issues related to the current state of the workforce, key issues in career development, ethics and liability issues in research, funding of research, drug development research, and the leadership required for the development of research capacity within departments of obstetrics and gynecology. Each workshop was open to the public; and individuals were invited to present information to the committee, discuss their presentations, and address inquiries from the committee. The agendas of these workshops, including the names of the workshop participants, are included in Boxes A-1 through A-3.

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Preterm Birth: Causes, Consequences, and Prevention BOX A-1 Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes The National Academies Building 2100 C Street, NW Washington, D.C. Room 150 AGENDA Wednesday March 30, 2005 12:30 p.m. WELCOME AND INTRODUCTIONS Richard E. Behrman, M.D. Chair, Committee on Understanding Premature Birth and Assuring Healthy Outcomes   OVERVIEW OF KEY ISSUES 12:45 p.m. Pathogenesis of Prematurity Charles J. Lockwood, M.D. Chair, Department of Obstetrics and Gynecology Yale School of Medicine 1:15 p.m. Discussion 1:30 p.m. Educational and Family Sequelae of Prematurity: Findings from Naturalistic and Experimental Studies Sharon Landesman Ramey, Ph.D. Professor, School of Nursing and Health Studies Georgetown University 1:50 p.m. Economic Consequences of Prematurity Scott Grosse, Ph.D. Senior Health Economist, National Center for Birth Defects and Developmental Disabilities Centers for Disease Control and Prevention

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Preterm Birth: Causes, Consequences, and Prevention 2:10 p.m. Impact of Prematurity: A Parent Perspective Kathy Paz President and Founder Preemies Today 2:30 p.m. Discussion 3:00 p.m. BREAK 3:15 p.m. DELIVERY OF STUDY CHARGE Duane Alexander, M.D. Director, National Institute of Child Health and Human Development National Institutes of Health Scott Grosse, Ph.D. Senior Health Economist, National Center for Birth Defects and Developmental Disabilities Eve M. Lackritz, M.D. Chief, Maternal and Infant Health Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention 3:45 p.m. DISCUSSION OF STUDY CHARGE Richard Schwarz, M.D. Vice Chair of Obstetrics and Gynecology Maimonides Medical Center Michael Katz, M.D. Senior Vice President for Research and Global Programs March of Dimes Birth Defects Foundation Enriqueta C. Bond, Ph.D. President The Burroughs Wellcome Fund

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Preterm Birth: Causes, Consequences, and Prevention   Ann Koontz, C.N.M., Dr.P.H. Associate Director, Division of Perinatal Systems and Women’s Health Maternal and Child Health Bureau, Health Resources and Services Administration Loretta Finnegan, M.D. Medical Advisor for the Director, Office of Research on Women’s Health National Institutes of Health Debra Hawks, M.P.H. Director, Practice Activities American College of Obstetricians and Gynecologists Sean Tipton Director of Public Affairs American Society for Reproductive Medicine Arnold Cohen, M.D. Chairman, Department of Obstetrics and Gynecology, Albert Einstein Medical Center Society for Maternal-Fetal Medicine 5:15 p.m. ADJOURN

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Preterm Birth: Causes, Consequences, and Prevention BOX A-2 Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes The National Academies Building 2100 C Street, NW Washington, D.C. Room 180 AGENDA Wednesday, June 22, 2005 7:30 a.m. WELCOME AND INTRODUCTIONS Richard E. Behrman, M.D. Chair, Committee on Understanding Premature Birth and Assuring Healthy Outcomes 7:45 a.m. THE ROLE OF INFECTION AND INFLAMMATION IN PREMATURE BIRTH Prenatal Infection and Inflammation Robert Goldenberg, M.D. Department of Obstetrics and Gynecology University of Alabama at Birmingham 8:30 a.m. Discussion 8:45 a.m. Antenatal and Postnatal Inflammation Effects on the Preterm Lung Alan Jobe, M.D., Ph.D. Department of Pediatrics Cincinnati Children’s Hospital Medical Center 9:05 a.m. Inflammation and Perinatal Brain Damage Michael O’Shea, M.D., M.P.H. Department of Pediatrics Wake Forest University School of Medicine 9:25 a.m. Discussion 10:00 a.m. BREAK

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Preterm Birth: Causes, Consequences, and Prevention 10:15 a.m. Preeclampsia: Maternal/Fetal Mortality and Morbidity John Hauth, M.D. Department of Obstetrics and Gynecology University of Alabama School of Medicine 10:45 a.m. Discussion 11:15 a.m. EPIDEMIOLOGY OF PRETERM BIRTH Michael Kramer, M.D. Departments of Pediatrics and Epidemiology and Biostatistics McGill University 12:00 a.m. Discussion 12:30 p.m. LUNCH 1:30 p.m. OVERVIEW OF POLICIES RELATING TO PRETERM DELIVERY Wendy Chavkin, M.D., M.P.H. Department of Population and Family Health Columbia University’s Mailman School of Public Health 2:00 p.m. Discussion

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Preterm Birth: Causes, Consequences, and Prevention 2:15 p.m. CONTROVERSIAL ISSUES IN NEONATAL CARE F. Sessions Cole, M.D. Department of Pediatrics Washington University School of Medicine Jerold F. Lucey, M.D. Department of Pediatrics University of Vermont College of Medicine Robert M. Nelson, M.D., Ph.D. Department of Anesthesia and Critical Care Medicine The Children’s Hospital of Philadelphia 4:00 p.m. ADJOURN—Reception Thursday, June 23, 2005 Room 180 8:30 a.m. Racial Disparities in Preterm Delivery: Health Care and Research Issues Carol Rowland Hogue, Ph.D., M.P.H. Department of Epidemiology Emory University School of Public Health 9:30 a.m. ADJOURN

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Preterm Birth: Causes, Consequences, and Prevention BOX A-3 Institute of Medicine Committee on Understanding Premature Birth and Assuring Healthy Outcomes Keck Center of the National Academies 500 Fifth Street, NW Washington, D.C. Room 100 Public Workshop on Barriers to Clinical Research Related to Premature Birth Wednesday, August 10, 2005 8:30 a.m. Welcome and Introductions Richard Behrman, M.D., J.D. Chair, Committee on Understanding Premature Birth and Assuring Healthy Outcomes 8:45 a.m. Nurse-Midwife Workforce Kerri Durnell Schuiling, Ph.D., C.N.M, F.A.C.N.M. Professor and Associate Dean for Nursing Education Northern Michigan University Senior Staff Researcher, American College of Nurse-Midwives 9:00 a.m. Discussion 9:15 a.m. Career Development Jerome F. Strauss III, M.D., Ph.D. Professor and Director, Center for Research on Reproduction and Women’s Health University of Pennsylvania Medical Center 9:30 a.m. Diane Magrane, M.D. Associate Vice President, Faculty Development and Leadership Programs Association of American Medical Colleges 9:45 a.m. Discussion 10:15 a.m. BREAK

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Preterm Birth: Causes, Consequences, and Prevention 10:30 a.m. Funding of Research on Premature Birth John V. Ilekis, Ph.D. Health Scientist Administrator, Pregnancy and Perinatology Branch Center for Developmental Biology and Perinatal Medicine National Institutes of Health National Institute of Child Health and Development 10:50 a.m. William Callaghan, M.D., M.P.H. Senior Scientist, Maternal and Infant Health Branch Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention 11:05 a.m. Enriqueta C. Bond, Ph.D. President Burroughs Wellcome Fund 11:20 a.m. Nancy Green, M.D. Medical Director March of Dimes 11:35 a.m. Discussion 1:00 p.m. Ethical and Liability Issues in Reproductive Research Robert M. Nelson, M.D., Ph.D. Associate Professor of Anesthesiology and Critical Care University of Pennsylvania School of Medicine The Children’s Hospital of Philadelphia 1:10 p.m. Robert Goldenberg, M.D. Professor of Obstetrics and Gynecology University of Alabama at Birmingham 1:20 p.m. John M. Gibbons, Jr., M.D. Professor of Obstetrics and Gynecology University of Connecticut School of Medicine Past President, American College of Obstetricians and Gynecologist

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Preterm Birth: Causes, Consequences, and Prevention 1:30 p.m. Discussion 2:00 p.m. Training Required for Future Reproductive Research Sudhansu K. Dey, Ph.D. Professor, Department of Pediatrics, Departments of Cell and Developmental Biology and Pharmacology Vanderbilt University 2:15 p.m. Jeff Reese, M.D. Associate Professor, Department of Pediatrics Vanderbilt University 2:30 p.m. Discussion 3:00 p.m. Theodore M. Danoff, M.D., Ph.D Director, Discovery Medicine Hypertension, PTL, Renal and Thrombosis Disease Area Glaxo Smith Kline 3:15 p.m. Discussion 3:35 p.m. BREAK 3:50 p.m. Robert Goldenberg, M.D. Professor, Department of Obstetrics and Gynecology University of Alabama at Birmingham Jerome F. Strauss III, M.D., Ph.D. Professor and Director, Center for Research on Reproduction and Women’s Health University of Pennsylvania Medical Center

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Preterm Birth: Causes, Consequences, and Prevention   Linda J. Heffner, M.D., Ph.D. Professor and Chair, Department of Obstetrics and Gynecology Boston University Medical Center David Eschenbach, M.D. Professor and Chair, Department of Obstetrics and Gynecology University of Washington Garland D. Anderson, M.D. Professor and Chair, Department of Obstetrics and Gynecology University of Texas Medical Branch Katherine E. Hartmann, M.D., Ph.D. Director, Center for Women’s Health Research University of North Carolina 4:45 p.m. Discussion 5:30 p.m. Adjourn Thursday, August 11, 2005 Room 110 9:00 a.m. Economic Costs of Premature Birth Stavros Petrou, M.Phil., Ph.D. National Perinatal Epidemiology Unit University of Oxford 10:30 a.m. Adjourn