Autopsy Findings in A Prospective Study on the Role of Prenatal Alcohol Exposure in SIDS and Stillbirth

Participants enrolled in the main study during the prenatal period and whose child dies within or around one year (adjusted age) will be approached to participate in the infant death component of the study. Specifically, events involving premature infants who are live born and die in the hospital, term infants who die in the hospital, infants discharged from and then readmitted to the hospital, and sudden and unexpected infant deaths that occur outside the hospital will be approached for participation. Participation in the infant death component of the study will not interfere with the family’s traditional ceremonies, customs or services. Upon death, the infant’s body will be delivered to the pathologist for an autopsy at which time the study researchers will be contacted by the pathologists. This dataset contains the autopsy findings recorded via the Annotated 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.

产前阶段纳入主研究、且其子女在矫正年龄（adjusted age）1岁以内或左右死亡的参与者，将受邀参与本研究的婴儿死亡子研究。具体而言，以下情形的婴儿将被邀请参与：活产早产并在医院内死亡的早产儿、足月产并在医院内死亡的足月儿、出院后再次入院的婴儿，以及院外发生的婴儿猝死意外事件。参与本婴儿死亡子研究不会干扰家属的传统丧葬仪式、习俗或相关服务。婴儿身故后，其遗体将被送至病理学家处进行尸检（autopsy），届时病理学家将联系本研究的研究人员。本数据集包含通过《标注式尸检数据采集表（Annotated Autopsy Data Collection Form）》记录的尸检结果。

研究描述
“安全通行研究（Safe Passage Study）”是一项大型前瞻性多学科研究，旨在实现两大核心目标：其一，探究产前酒精暴露与婴儿猝死综合征（Sudden Infant Death Syndrome, SIDS）、死产（stillbirth）之间的关联；其二，明确酒精暴露所引发的表型结局谱系的生物学基础，该谱系会因增加死产、SIDS风险的环境与遗传因素，以及存活儿童罹患胎儿酒精谱系障碍（Fetal Alcohol Spectrum Disorders, FASD）的风险而发生改变。
本研究招募了来自美国北部平原（Northern Plains）与南非开普敦（Cape Town）的孕妇，上述区域均为孕期女性饮酒高风险地区。研究随访覆盖产前、分娩/新生儿期以及产后1年内的多个阶段。
“安全通行研究”是首个针对SIDS与死产的多中心研究，采用统一研究方案（study protocol），在同一母婴/婴儿配对样本（maternal and fetal/infant dyad）中整合前瞻性收集的暴露信息与多学科生物学信息。本研究设计与项目成功的核心要素，在于与社区建立的紧密协作关系，以及确保研究方案与流程得到严格遵守的严谨体系与规范流程。
本研究的参与者包括从美国北部平原与南非招募的孕妇及婴儿，选取上述区域的目的是确保能够招募到足够数量的、存在高酒精暴露且妊娠结局不良（包括SIDS、死产或胎儿酒精谱系障碍）的孕妇。