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

描述（由申请人提供）：2006年，NICHD/NIAAA/ nidcd资助的PASS网络（第11期）启动了一项前瞻性研究，从产前酒精暴露、小婴儿猝死症、死胎和FASD高危人群中招募约12,000名孕妇，随访其婴儿至出生后一年（小婴儿猝死症的时间框架）。本申请是根据RFA-HD-10-018完成研究参与者的入组和随访，监督数据收集、数据清理和管理，并进行统计分析。这个特殊的应用程序属于PASS网络的数据协调和分析中心（DCAC）。安全通道研究的长期目标是降低胎儿和婴儿死亡率，改善孕妇产前饮酒高风险社区的儿童健康。PASS网络的主要假设是，产前酒精暴露会增加小岛屿发展中国家和死产的风险。次要假设考察了产前酒精暴露与其他母体和环境因素之间的相互作用对胎盘的功能和结构、胎儿和婴儿面部发育、自主神经功能、听力和胎儿和/或婴儿的皮质活动、胎儿生长和体内大脑发育的影响，以及胎儿和婴儿尸检研究中脑干和大脑皮层的神经递质和突触成熟的影响。PASS网络提供产前酒精暴露与不良围产期结局之间潜在关联的准确有效证据的能力取决于网络调查人员之间的广泛合作以及高质量数据的收集和分析，所有这些都由DCAC提供便利。DCAC的任务是与PASS网络的调查人员和社区合作：(1)发展和维护一个网络范围的基础设施，作为通信和信息交流的工具，以促进PASS网络内的合作，并向网络的所有成员提供后勤和行政支持；(2)向帕斯网络提供生物统计和流行病学专门知识；(3)领导PASS网络的协议开发和实施；(4)为PASS网络提供集中、高效、经济、优质的数据管理；(5)支持网络管理委员会的需要。

DESCRIPTION (provided by applicant): In 2006, the NICHD/NIAAA/NIDCD-funded PASS Network (Phase 11) initiated the planned enrollment of approximately 12,000 pregnant women from high-risk populations for prenatal alcohol exposure, SIDS, stillbirth, and FASD in a prospective study with follow-up of their infants to one postnatal year ( the time- frame for SIDS). This application is in response to RFA-HD-10-018 to complete enrollment and follow-up with study participants, oversee data collection, data cleaning and management, and conduct statistical analysis. This particular application pertains to the Data Coordinating and Analysis Center (DCAC) of the PASS Network. 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 primary hypothesis of the PASS Network is that prenatal alcohol exposure increases the risk for SIDS and stillbirth. Secondary hypotheses examine the role of interactions between prenatal alcohol exposure and other maternal and environmental factors upon the function and structure of the placenta, development of the fetal and infant face, autonomic function, hearing, and cortical activity in the fetus and/or infant, fetal growth and in vivo brain development with ultrasonography, and neurotransmitter and synaptic maturation in the brainstem and cerebral cortex in autopsy studies of the fetus and infant. The ability of the PASS Network to provide accurate and valid evidence of potential associations between prenatal alcohol exposure and adverse perinatal outcomes depends on extensive collaboration among the Network investigators and the collection and analysis of high quality data, all of which is facilitated by the DCAC. The mission of the DCAC is to work collaboratively with the investigators of the PASS Network and communities to: (1) Develop and maintain a network-wide infrastructure as a vehicle for communication and information exchange for the promotion of collaboration within the PASS Network and for the provision of logistical and administrative support to all members of the Network; (2) Provide biostatistical and epidemiological expertise to the PASS Network; (3) Provide leadership in protocol development and implementation for the PASS Network; (4) Provide centralized, efficient, cost-effective and quality data management to the PASS Network; and (5) To support the needs of the Network governing boards.