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

婴儿猝死综合症和死产中的产前酒精 (PASS) 网络

• 批准号: 7162681
• 负责人: Kimberly A. Dukes
• 金额: $ 72.14万
• 依托单位: DM-STAT, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7162681
• 关键词: alcoholic beverage consumption; clinical research; computer center; cooperative study; data collection methodology /evaluation; data management; ethanol; fetal alcohol syndrome; health behavior; human data; information dissemination; information systems; interview; lactation; medical records; outcomes research; pregnancy loss; prenatal stress; statistics /biometry; sudden infant death syndrome

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 of 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 Data Coordinating and Analysis Center (DCAC) of the PASS Network. The experimental design involves a prospective study of 12,000 pregnancies, and two retrospective, autopsy-based 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 DCAC is to work collaboratively with the investigators of the PASS Network to develop an infrastructure for information exchange, quality data management, and statistical analysis. In addition, the DCAC will provide leadership in protocol development, study setup, biostatistician expertise, project management, data management, information technology and logistical and administrative support to all members of the PASS Network.

描述（由申请人提供）：此申请是响应邀请信（LOI-HD-05-111）进行社区关联研究，以调查产前酒精暴露在SIDS，Stilts，Stiltbirth和FAS风险中的作用，并确定如何确定这些不同的结果是相互关联的。拟议的研究将由与NICHD和NIAAA的合作协议中的产前酒精，SIDS和Stilt Birth（Pass）研究网络的研究人员进行。这项研究涉及以下合作：1）两个全面的临床场所，为人群提供高风险的人口，小岛屿发展中国家和死产，即北部平原的美洲印第安人，以及南非开普敦的开普山。 2）中央发育生物学和病理中心（DBPC）； 3）中央数据协调和分析中心（DCAC）； 4）中央生理评估中心（PAC）； 5）NICHD和NIAAA的计划科学家和官员。该特定的应用程序与PASS网络的数据协调和分析中心（DCAC）有关。实验设计涉及对12,000例怀孕的前瞻性研究，以及两项回顾性的，基于尸检的SID和死产研究。安全通道研究的长期目标是降低胎儿和婴儿死亡率，并改善产前孕妇饮酒风险高风险的社区的儿童健康。 网络的具体目的如下：1）确定产前酒精暴露与SID和死产风险之间的关联； 2）确定产前酒精暴露和其他环境因素在人类早期生命中发病和死亡的风险中的作用； 3）确定特定基因在改变与产前酒精相关的早期发病率和死亡率的风险中的作用； 4）确定妊娠期间酒精暴露的作用，以及酒精暴露以及环境和遗传修饰符之间的相互作用，在改变胎儿和婴儿的自主活动的特征以及婴儿的神经行为结局中； 5）确定受特定环境和遗传因素的影响在胎盘功能受损中的孕产妇暴露的作用，从而增加胎儿和/或婴儿发病率和死亡的风险； 6）确定胎儿和/或婴儿的关键神经递质系统的异常，这些系统传达了猝死风险，并确定受特定的环境和遗传因素的影响，并确定产前酒精暴露的作用。 DCAC的使命是与通行网络的研究人员合作，开发用于信息交换，质量数据管理和统计分析的基础架构。此外，DCAC将向通行网络的所有成员提供方案开发，研究设置，生物统计学专业知识，项目管理，数据管理，信息技术以及后勤支持和行政支持的领导能力。