Brain Tissue - Neuropathology 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. This dataset contains all information on brain tissue - neuropathology as recorded by the Developmental Biology and Pathology Center from the Annotated Neuropathology data collection forms.
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.

在产前阶段纳入主研究，且其子女在矫正月龄1年以内或前后死亡的参与者，将被邀请参与本研究的婴儿死亡子课题。具体而言，本研究将邀请以下情形的参与者家属：活产早产儿在医院内死亡、足月儿在医院内死亡、出院后再次入院的婴儿，以及院外发生的婴儿突发意外死亡事件。参与本婴儿死亡子课题不会干扰家属的传统丧葬仪式、习俗或相关服务。本数据集包含发育生物学与病理中心（Developmental Biology and Pathology Center）通过《注释版神经病理学数据采集表》（Annotated Neuropathology data collection forms）记录的全部脑组织神经病理学（neuropathology）相关信息。

研究说明
《安全通行研究》（Safe Passage Study）是一项大型前瞻性多学科研究，旨在完成两项核心任务：其一，探究产前酒精暴露与婴儿猝死综合征（sudden infant death syndrome, SIDS）、死产之间的关联；其二，明确酒精暴露所致表型结局谱系的生物学机制，该机制会受到增加死产、SIDS风险的环境与遗传因素，以及存活儿童所患胎儿酒精谱系障碍（fetal alcohol spectrum disorders, FASD）的调控。本研究招募了美国北部平原地区与南非开普敦地区的孕妇，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，以及分娩后1年内的产后阶段。《安全通行研究》是首个针对SIDS与死产的多中心研究，通过统一方案在同一母婴配对样本中整合前瞻性收集的暴露信息与多学科生物学数据。本研究设计与项目成功的核心要素包括：与社区建立紧密合作关系，以及建立严格的体系与流程以确保研究方案与操作流程得到严格执行。本研究的研究对象包括从美国北部平原与南非招募的孕妇及婴儿，上述区域的选取旨在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（如发生SIDS、死产或胎儿酒精谱系障碍）的孕妇。