Safe PASSage Study Administrative Supplement - Effects of Overnight Maternal Slee

描述(由申请人提供)：2006年，NICHD/NIAAA/NIDCD资助的PASS网络(第11阶段)启动了一项前瞻性研究，计划招募约12,000名来自高危人群的孕妇参加产前酒精暴露、小岛屿发展中国家、死产和FASD，并对其婴儿出生后一年(小岛屿发展中国家的时间范围)进行跟踪。该应用程序是对RFA-HD-10-018的响应，以完成研究参与者的登记和跟踪，监督数据收集、数据清理和管理，并进行统计分析。这一特殊应用属于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在产前孕妇饮酒的高危社区降低胎儿和婴儿死亡率并改善儿童健康。PASS网络的主要假设是，产前酒精暴露会增加婴儿猝死综合征和死产的风险。第二个假设考察了产前酒精暴露与其他母体和环境因素相互作用对胎盘的功能和结构、胎儿和婴儿面部发育、胎儿和/或婴儿的自主神经功能、听力和皮质活动、胎儿生长和活体脑发育的超声检查，以及在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作用。PASS网络能否提供准确和有效的证据，证明产前酒精暴露与不良围产期结局之间的潜在关联，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，所有这些都得到了DCAC的协助。DCAC的任务是与PASS网络和社区的调查人员合作：(1)开发和维护全网络的基础设施，作为促进PASS网络内的合作和向PASS网络所有成员提供后勤和行政支助的沟通和信息交流的工具；(2)向PASS网络提供生物统计学和流行病学方面的专门知识；(3)领导PASS网络的协议制定和执行；(4)向PASS网络提供集中、高效、成本效益高和高质量的数据管理；以及(5)支持PASS网络理事会的需要。

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.