This application is in response to a Letter of Invitation (LOI-HD-05-111) to conduct community-linked studies to investigate the role of prenatal alcohol exposure in the risk for SIDS, stillbirth and FAS, and to determine how these different outcomes are inter-related. The proposed research will be conducted by the investigators the Prenatal Alcohol, SIDS, and Stillbirth (PASS) Research Network in a cooperative agreement with NICHD and NIAAA. This research involves the collaboration of: 1) two comprehensive clinical sites serving populations that are high risk for rental alcohol exposure, SIDS, and stillbirth, i.e. the American Indians in the Northern Plains and the Cape Coloured in Cape Town, South Africa;2) a central Developmental Biology and Pathology Center (DBPC);3) a central Data Coordinating and Analysis Center (DCAC);4) a central Physiology Assessment Center (PAC);and 5) program scientists and officers at the NICHD and NIAAA. This particular application pertains to the Northern Plains Comprehensive Clinical Site (CCS) of the PASS Network. The experimental design involves a prospective study of 12,000 pregnancies, and two retrospective, autopsy-based studies of SIDS and stillbirth. 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 Specific Aims of the Network are as follows: 1) to determine the association between prenatal alcohol exposure and the risk for SIDS and stillbirth;2) to determine the role of the timing, pattern, and amount of prenatal alcohol exposure and other environmental factors in the risk for morbidity and mortality in early human life;3) to determine the role of specific genes in modifying the risk for morbidity and mortality in early life that is associated with prenatal alcohol exposure;4) to determine the role of alcohol exposure during pregnancy, and interactions among alcohol exposure and environmental and genetic modifiers, in altering profiles of autonomic activity of the fetus and infant, and neurobehavioral outcomes in the infant;5) to determine the role of maternal alcohol exposure, as influenced by specific environmental and genetic factors, in the impairment of placental function, and thereby the increased risk for fetal and/or infant morbidity and mortality;and 6) to determine abnormalities in key neurotransmitter systems in the brains of fetuses and/or infants that convey risk for sudden death, and to determine the role of prenatal alcohol exposure, as influenced by specific environmental and genetic factors, in their pathogenesis. The Northern Plains CCS is committed to closely working with community partners on the Safe Passage Studies and implementing study protocols for the PASS Network.

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 #
3U01HD045935-11S2
Application #
8701800
Study Section
Special Emphasis Panel (ZAA1 (02))
Program Officer
Raju, Tonse N
Project Start
2003-09-26
Project End
2016-07-31
Budget Start
2013-08-01
Budget End
2014-07-31
Support Year
11
Fiscal Year
2013
Total Cost
$158,954
Indirect Cost
$59,608
Name
Sanford Research/Usd
Department
Type
DUNS #
050113252
City
Sioux Falls
State
SD
Country
United States
Zip Code
57104
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
Brito, Natalie H; Fifer, William P; Myers, Michael M et al. (2016) Associations among family socioeconomic status, EEG power at birth, and cognitive skills during infancy. Dev Cogn Neurosci 19:144-51
Haynes, Robin L; Folkerth, Rebecca D; Paterson, David S et al. (2016) Serotonin Receptors in the Medulla Oblongata of the Human Fetus and Infant: The Analytic Approach of the International Safe Passage Study. J Neuropathol Exp Neurol :
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
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
Hofmeyr, F; Groenewald, C A; Nel, D G et al. (2014) Fetal heart rate patterns at 20 to 24 weeks gestation as recorded by fetal electrocardiography. J Matern Fetal Neonatal Med 27:714-8
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
Folkerth, Rebecca D; Habbe, Donald M; Boyd, Theonia K et al. (2013) Gastroschisis, destructive brain lesions, and placental infarction in the second trimester suggest a vascular pathogenesis. Pediatr Dev Pathol 16:391-6
Paintner, Ashley; Williams, Andrew D; Burd, Larry (2012) Fetal alcohol spectrum disorders-- implications for child neurology, part 1: prenatal exposure and dosimetry. J Child Neurol 27:258-63
Paintner, Ashley; Williams, Andrew D; Burd, Larry (2012) Fetal alcohol spectrum disorders--implications for child neurology, part 2: diagnosis and management. J Child Neurol 27:355-62

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