Autopsy Report - Retro in A Prospective Study on the Role of Prenatal Alcohol Exposure in SIDS and Stillbirth

This dataset contains data for the Retrospective Safe Passage Study. Parents who have a post-discharge, sudden unexpected death of an infant within the first year of life in the catchment areas and are not enrolled in the Prospective Study are approached for recruitment into the Retrospective SIDS Study. Participation in the study does not interfere with the family’s traditional ceremonies, customs or services. Upon death, the infant’s body is delivered to the Medical Examiner for an autopsy at which time the Principal Investigator/Clinical Coordinator is contacted by the Medical Examiner, Coroner, Forensic Pathology Laboratory staff, emergency rooms or pathology department. This dataset contains the autopsy findings recorded via the Annotated Retrospective Autopsy data collection form.
Study Description
The Safe Passage Study was a large, prospective, multidisciplinary study designed to (1) investigate the association between prenatal alcohol exposure, sudden infant death syndrome (SIDS), and stillbirth, and (2) determine the biological basis of the spectrum of phenotypic outcomes from exposure, as modified by environmental and genetic factors that increase the risk of stillbirth, SIDS, and in surviving children, fetal alcohol spectrum disorders. The study enrolled pregnant people from the Northern Plains, US, and Cape Town, South Africa, areas known to be of high risk for maternal drinking during pregnancy. Research visits occurred during prenatal, delivery/newborn, and postnatal periods through 1 year post-delivery. The Safe Passage Study was the first multi-site study of SIDS and stillbirth to integrate prospectively collected exposure information with multidisciplinary biological information in the same maternal and fetal/infant dyad using a common protocol. Essential components of the study design and its success were close ties to the community and rigorous systems and processes to ensure compliance with the study protocol and procedures. Study participants included pregnant people and infants recruited from the Northern Plains, USA and South Africa, areas selected to ensure an adequate number of pregnant women with high alcohol exposure yielding poor outcomes, SIDS, stillbirth or FASD.