New PPB-Supported Networks

In addition to the aforementioned Networks and studies, the PPB initiated four new networks since its last report to the NACHHD Council. These new projects are highlighted below.

Maternal Fetal Surgery Network
Community Child Health Research Network (CCHN)
Prenatal Alcohol in SIDS and Stillbirth (PASS) Network
Stillbirth Collaborative Research Network (SCRN)

Maternal Fetal Surgery Network 

 In 2001, the PPB created the Maternal Fetal Surgery Network to evaluate in utero surgery as a treatment for antenatally diagnosed spina bifida in a randomized clinical trial. The Management of Meningomyelocele Study (MOMS) trial includes three sites: the Children’s Hospital of Philadelphia, the Vanderbilt University Medical Center, and the University of California at San Francisco. The PPB provides additional oversight and guidance, and the George Washington Biostatistics Center serves as the data center for the Network. This collaborative, five-year, multicenter trial is comparing the safety and efficacy of fetal surgical repair and traditional postnatal repair of open neural tube defects. For more information on the MOMS trial or on the Network, visit http://www.spinabifidamoms.com/english/index.html.

Community Child Health Research Network (CCHN)

The CCHN represents Phase I of a community-linked research effort on maternal and child health. Through cooperative agreements, the community-linked Network will work over a three-year span to plan a multisite, multilevel study that examines how community, family, and individual-level influences interact with biological influences to result in health disparities in pregnancy outcomes and in infant and early childhood mortality and morbidity. The goal of the Phase I research program is to blend substantive theory, measurement regimes, and study designs found in the biomedical, social, and behavioral sciences into a study of infant mortality and child health. Findings garnered from this study will improve understanding of the complicated interplay of environmental and genetic factors that produces biological outcomes in high-risk minority populations.

The current products of Phase I include a plan of action that describes the hypotheses, design, and content of a multisite, multilevel study, as well as preliminary work at each site that will provide a foundation upon which to build such a Network. The CCHN includes five collaborating sites, each one a partnership between an academic institution and community institutions, and staff from the PPB, from the NICHD Demographic and Behavioral Sciences Branch, and from the National Institute on Nursing Research. The CCHN has made progress toward its core hypotheses, methods development, and study design. One of the foci of the research enterprise will be to improve family heath in the interconceptional period as a means to improve the outcomes of future pregnancies.

Prenatal Alcohol in SIDS and Stillbirth (PASS) Network

In 2003, the NICHD and NIAAA began funding four cooperative agreements to create a Network that would develop community-linked studies to investigate the role of prenatal alcohol exposure in the risk for SIDS and adverse pregnancy outcomes, such as stillbirth and fetal alcohol syndrome, and how they may be interrelated. The PASS Network is composed of two comprehensive clinical sites, a developmental biology and pathology center, and a data coordinating and analysis center. Investigators will work collaboratively with the PPB and the NIAAA over a three-year period to plan and pilot multidisciplinary investigations, using common protocols, within communities at high risk for prenatal maternal alcohol consumption. The comprehensive clinical sites will be working with Northern Plains Indian communities and with populations in the Western Cape of South Africa. In the long term, this initiative aims to decrease fetal and infant mortality and to improve child health in these communities.

Stillbirth Collaborative Research Network (SCRN) 

 Stillbirth, defined as death at 20 weeks' gestation or greater, account for a large proportion of perinatal mortality. According to annual national vital statistics, the number of fetal deaths at 20 weeks or more gestation, including stillbirths, is similar in magnitude to the total number of infant deaths in the United States. In 2001, there were 27,568 infant deaths, and 26,373 fetal deaths. More than half of the fetal deaths occurred at 28 weeks' gestation or more, and 20 percent, or about 5,000 cases, were at term gestation. In addition, the cause of about half of all stillbirths is undetermined.

On March 26, 2001, the PPB convened a workshop with experts in the field to set a national agenda for stillbirth research. Participants identified gaps in current knowledge that hamper progress in this field, as well as problems associated with current data on stillbirths in the United States, including:

• Fetal death reports are voluntary, and under-reporting of stillbirths may be as high as 10 percent to 15 percent;
• Variability exists in the quality and completeness of fetal death certificates, including identification of the cause of death;
• No standard protocol is available for postmortem investigation of stillbirths, including serologic, toxicologic, and genetic tests;
• Although placental pathology is common, fetal autopsy rates are low; and
• Few geographic, population-based, detailed investigations of reproductive and fetal risks associated with stillbirth are available.

To begin to address these gaps, the PPB issued Research on the Scope and Causes of Stillbirth in the United States (RFA-HD-02-025), to create a Network of clinical research sites with a central data collection and analysis resource for developing and implementing common research protocols to study stillbirth (defined as fetal death at 20 weeks' gestation or more). The objectives of the initiative are to:

• Develop a standard stillbirth postmortem protocol that includes review of clinical history, protocols for autopsies, pathologic examinations of the fetus and placenta, and other postmortem tests to illuminate genetic, maternal, and other environmental influences.
• Obtain a geographic, population-based determination of the incidence of stillbirth, its causes, and risk factors via a geographic, population-based study of stillbirths enrolled at the time of demise and a sub-cohort, case-controlled study.

The awards for the SCRN were made in September 2003, to the following clinical investigators and research sites: Dr. Marshall Carpenter, Women and Infants Hospital of Rhode Island, Providence; Dr. Donald Dudley, University of Texas Health Sciences Center, San Antonio; Dr. George Saade, University of Texas Medical Branch, Galveston; Dr. Robert Silver, University of Utah, Salt Lake City; Dr. Barbara Stoll, Emory University, Atlanta; and Dr. Corette Parker, Statistical Center at Research Triangle Institute, Raleigh. Investigators have made progress made toward the development of a standard postmortem protocol, as well as of protocols for surveillance and investigations into the associated risks and mechanisms of death.

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