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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD055154-12
Application #
8728661
Study Section
Special Emphasis Panel (ZAA1-GG (02))
Program Officer
Raju, Tonse N
Project Start
2003-09-30
Project End
2016-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
12
Fiscal Year
2014
Total Cost
$1,037,272
Indirect Cost
$387,656
Name
Dm-Stat, Inc.
Department
Type
DUNS #
009882820
City
Malden
State
MA
Country
United States
Zip Code
02148
Dukes, Kimberly; Tripp, Tara; Petersen, Julie et al. (2017) A modified Timeline Followback assessment to capture alcohol exposure in pregnant women: Application in the Safe Passage Study. Alcohol 62:17-27
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Geldenhuys, Elaine; Coldrey, Jean; Wright, Colleen et al. (2017) Fetal foot length at delivery as a tool for determining gestation length in non-macerated stillbirths. Int J Gynaecol Obstet 138:107-112
Dukes, Kimberly; Tripp, Tara; Willinger, Marian et al. (2017) Drinking and smoking patterns during pregnancy: Development of group-based trajectories in the Safe Passage Study. Alcohol 62:49-60
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Angal, Jyoti; Petersen, Julie M; Tobacco, Deborah et al. (2016) Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains. J Empir Res Hum Res Ethics 11:91-6
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Himes, Sarah K; Dukes, Kimberly A; Tripp, Tara et al. (2015) Clinical sensitivity and specificity of meconium fatty acid ethyl ester, ethyl glucuronide, and ethyl sulfate for detecting maternal drinking during pregnancy. Clin Chem 61:523-32
Noble, Kimberly G; Engelhardt, Laura E; Brito, Natalie H et al. (2015) Socioeconomic disparities in neurocognitive development in the first two years of life. Dev Psychobiol 57:535-51

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