Prenatal Alcohol in Sudden Infant Death Syndrome and Stillbirth (PASS) Network

描述（由申请人提供）：本申请是对邀请函（LOI-HD-05-111）的回应，邀请函旨在开展社区相关研究，以调查产前酒精暴露在SIDS、死产和FAS风险中的作用，并确定这些不同结局之间的相互关系。拟议的研究将由产前酒精，SIDS和死产（PASS）研究网络的研究人员与NICHD和NIAAA达成合作协议。这项研究涉及以下机构的合作：1）两个综合性临床研究中心，为产前酒精暴露、婴儿猝死综合症和死胎高危人群提供服务，即南非北方平原的美洲印第安人和开普敦的开普有色人种; 2）一个中央发育生物学和病理学中心（DBPC）; 3）一个中央数据协调和分析中心（DCAC）; 4）一个中央生理学评估中心（PAC）;和5）在NICHD和NIAAA的项目科学家和官员。该特定应用程序属于Tygerberg综合临床研究中心（CCS）。实验设计包括一项对7,000名孕妇的前瞻性研究， SIDS和死胎的研究。 安全通道研究的长期目标是降低胎儿和婴儿死亡率，改善产前母亲饮酒高风险社区的儿童健康。该网络的具体目标如下：1）确定产前酒精暴露与小岛屿发展中国家和死产风险之间的关系; 2）确定产前酒精暴露的时间、模式和数量以及其他环境因素在人类生命早期发病率和死亡率风险中的作用; 3）确定特定基因在改变与产前酒精暴露相关的早期生命发病率和死亡率风险中的作用; 4）确定妊娠期间酒精暴露的作用，以及酒精暴露与环境和遗传修饰剂之间的相互作用，改变胎儿和婴儿自主活动的概况，和婴儿的神经行为结果; 5）确定母亲酒精暴露在特定环境和遗传因素的影响下在胎盘功能受损中的作用，从而增加胎儿和/或婴儿发病率和死亡率的风险;和6.确定胎儿和/或婴儿大脑中传达猝死风险的关键神经递质系统的异常，并确定产前酒精暴露在其发病机制中的作用，受特定环境和遗传因素的影响。该中心的使命是确保正确识别怀孕期间饮酒的围产期风险，及早发现这些风险，并开展与酒精引起的人脑和胎盘损伤有关的基础研究。这项多学科的国际研究将确定胎儿在怀孕期间接触酒精是否会导致SIDS死胎和其他并发症。从研究中获得的知识将有助于卫生保健工作者为孕妇提供更好的护理。

DESCRIPTION (provided by applicant): 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 prenatal 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 Tygerberg Comprehensive Clinical Site (CCS). The experimental design involves a prospective study of 7,000 pregnancies, and two retrospective, autopsybased 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 mission of the CCS is to ensure the proper identification of the perinatal risks of the use of alcohol during pregnancy, early detection of these risks and to perform basic research related to alcohol-induced injury in the human brain and placenta. This multidiscipline international study will determine whether the exposure of the fetus to alcohol during pregnancy leads to SIDS stillbirths and other complications. Knowledge gained from the study will help health care workers to provide better care for pregnant women.