In 2006, the NICHD/NIAAA/NIDCD-funded PASS Network (Phase 11) initiated the planned enrollment of approximately 12,000 pregnant women from high-risk populations for prenatal alcohol exposure, SIDS, stillbirth, and FASD in a prospective study with follow-up of their infants to one postnatal year ( the time- frame for SIDS). This application is in response to RFA-HD-10-018 to complete enrollment and follow-up with study participants, oversee data collection, data cleaning and management, and conduct statistical analysis. This particular application pertains to the Data Coordinating and Analysis Center (DCAC) of the PASS Network. The long-term goals of the Safe Passage Study are to decrease fetal and infant mortality and improve child health in communities at high risk for prenatal maternal alcohol consumption. The primary hypothesis of the PASS Network is that prenatal alcohol exposure increases the risk for SIDS and stillbirth. Secondary hypotheses examine the role of interactions between prenatal alcohol exposure and other maternal and environmental factors upon the function and structure of the placenta, development of the fetal and infant face, autonomic function, hearing, and cortical activity in the fetus and/or infant, fetal growth and in vivo brain development with ultrasonography, and neurotransmitter and synaptic maturation in the brainstem and cerebral cortex in autopsy studies of the fetus and infant. The ability of the PASS Network to provide accurate and valid evidence of potential associations between prenatal alcohol exposure and adverse perinatal outcomes depends on extensive collaboration among the Network investigators and the collection and analysis of high quality data, all of which is facilitated by the DCAC. The mission of the DCAC is to work collaboratively with the investigators of the PASS Network and communities to: (1) Develop and maintain a network-wide infrastructure as a vehicle for communication and information exchange for the promotion of collaboration within the PASS Network and for the provision of logistical and administrative support to all members of the Network;(2) Provide biostatistical and epidemiological expertise to the PASS Network;(3) Provide leadership in protocol development and implementation for the PASS Network;(4) Provide centralized, efficient, cost-effective and quality data management to the PASS Network;and (5) To support the needs of the Network governing boards.

Public Health Relevance

The PASS Network will perform community-linked studies to determine the role of prenatal alcohol exposure in the risk for SIDS and adverse pregnancy outcomes, especially stillbirth and FASD. The study hopes to decrease fetal and infant death and improve child health in communities at high risk for prenatal maternal alcohol consumption.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZAA1-GG (02))
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Raju, Tonse N
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Dm-Stat, Inc.
United States
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Dukes, Kimberly A; Burd, Larry; Elliott, Amy J et al. (2014) The safe passage study: design, methods, recruitment, and follow-up approach. Paediatr Perinat Epidemiol 28:455-65
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