Friday, April 25, 2025
4/25/2025
Documenting and archiving the Safe Passage Study in NICHD Data and Specimen Hub (DASH) - PROJECT ABSTRACT The Safe Passage Study is the first prospective, observational, large-scale cohort study to investigate the effect of prenatal exposure to alcohol, tobacco and drugs on the risk for Sudden Infant Death Syndrome (SIDS), stillbirth, and Fetal Alcohol Spectrum Disorders (FASD). Participants were recruited from two sites in Cape Town, South Africa, and five sites in the Northern Plains, United States, including two American Indian Reservations between 2007 and 2015. In total, the study enrolled 10,088 women, 11,892 pregnancies, and 12,029 fetuses, followed to 1-year post-delivery. Extensive longitudinal data have been collected during prenatal, delivery/newborn, and postnatal stages. As such, the Safe Passage Study is an important resource for researchers interested in prenatal exposures, child physiological and neurological development, and pathological assessments of SIDS, stillbirth, and FASD. The Safe Passage Study was initiated prior to the NIH data sharing mandate, thus funds were not available for preparation and archiving of a de-identified dataset. To facilitate the use of this valuable resource, we propose to make publicly available the Safe Passage Study datasets via NICHD Data and Specimen Hub (DASH). We will archive and document the existing datasets of Safe Passage Study, which NICHD sponsored along with NIAAA and NIDCD. More specifically, we will 1.) prepare and submit PASS self-reported and medical chart abstraction data, such as maternal and infant characteristics, psychosocial and dietary information, and exposure assessments, to the DASH portal; and 2.) prepare and submit PASS physiology and pathology data, such as autonomic, respiratory, and brain function in the fetus and infant, pathology assessments from autopsy and placental evaluation, and neurologic assessments of the infant to the DASH portal. We will perform data de-identification, create a variable dictionary, prepare datasets and annotation files using the Data Preparation Tool, and submit the Safe Passage Study to NICHD DASH. De-identified data sets produced with support from this grant will be available without restriction to researchers with the exception of data collected on tribal lands, due to sharing restrictions negotiated at the onset of the study. The shared datasets will enable secondary analysis by the scientific community interested in the link between prenatal exposures and child development.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).