PRENATAL ALCOHOL IN SUDDEN INFANT DEATH SYNDROME AND STILLBIRTH (PASS)

描述（申请人提供）：本申请是回应一项申请要求（RFA-HD-10-018）进行社区相关研究，以调查产前酒精暴露在SIDS，死产和FASD风险中的作用，并确定这些不同结果如何相互关联，拟议的研究将由研究人员进行产前酒精，小岛屿发展中国家和死产研究网络与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、小岛屿发展中国家和死产的高危人群提供服务，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。我们研究中心的使命是通过招募和入组7，000名女性并执行所有涉及母体/胎儿二联体的假设驱动研究方案，实现安全通道研究的9个具体目标。SCCS正在监督具体目标3的执行和分析。本研究的目的是利用胎儿超声检查和婴儿面部成像以及标准化特征评估，确定产前酒精暴露（可能受其他环境、遗传和胎盘因素影响）对胎儿和婴儿面部特征、躯体生长和神经/大脑发育的作用。我们将测试以下假设：1）产前酒精暴露对人类胎儿早在妊娠20-24周的面部、躯体和/或大脑生长产生不利影响，即，US检查的最早时间点; 2）产前酒精暴露与面部畸形有关，面部畸形早在20-24周时通过面部成像鉴定，并在出生后1个月和12个月时仍然存在;和3）这种酒精毒性被其他环境和胎盘因素改变，例如母体营养、母体吸烟和胎盘灌注失败。

DESCRIPTION (provided by applicant): This application is in response to a Request for Application (RFA-HD-10-018) to conduct community-linked studies to investigate the role of prenatal alcohol exposure in the risk for SIDS, stillbirth and FASD, 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 Centre (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. The mission of our site is to accomplish the 9 Specific Aims of the Safe Passage Study through the recruitment and enrollment of 7,000 women and the performance of all of the hypothesis-driven study protocols involving the maternal/fetal dyads. The SCCS is overseeing the performance and analysis of Specific Aim 3. This aim is to determine the role of prenatal alcohol exposure, as potentially modified by other environmental, genetic, and placental factors, upon the facial features, somatic growth, and neurological/brain development in the fetus and infant utilizing fetal ultrasonography and infant facial imaging and standardized feature assessment. We will test the hypotheses that: 1) prenatal alcohol exposure adversely impacts facial, somatic, and/or brain growth in the human fetus as early as 20-24 gestational weeks, i.e., the earliest time-point examined by us; 2) prenatal alcohol exposure is associated with facial dysmorphology that is identified by imaging of the face as early as 20-24 weeks and remains present at 1 postnatal month and 12 postnatal months; and 3) this alcohol toxicity is modified by other environmental and placental factors, such as maternal nutrition, maternal smoking, and placental perfusion failure.