6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt

项目概要/摘要 在产前和整个童年时期，大脑发育速度很快，受动态遗传因素的影响， 和环境影响。使用先进的神经成像技术的研究为以下方面提供了重要的见解： 大脑发育，但由于样本量小，特别是对高危人群来说，受到限制。物质- 暴露的婴儿发生不良后果的风险特别高;然而，研究结果不一致， 很难将产前暴露影响与其他不良影响区分开来。我们的健康目标 大脑和儿童发育（六溴环十二烷） 联盟是为了描述从出生到童年大脑发育的典型轨迹， 测量关键的生物和环境因素及其相互作用对儿童社会的影响， 认知和情感的发展我们将评估产前暴露于阿片类药物和其他 物质，以及环境逆境，在这些大脑轨迹和结果不同。我方联合体 由六个中心组成（阿肯色州儿童研究所、凯斯西储大学、辛辛那提 儿童医院，儿童国家医疗中心，北卡罗来纳州大学查佩尔山，和 范德比尔特大学），它们以前曾合作过，并在神经成像方面具有互补的专业知识， 神经生理学，纵向临床研究，儿童发育，物质暴露和成瘾， 伦理/法律的问题和高危婴儿/儿童的临床护理。PRELUDE财团将招募680名 使用药物的孕妇，680名未使用药物的高危孕妇，1360名 对代表一般人群的孕妇进行比较，以促进整个六溴环十二烷研究。 我们将与其他研究中心、六溴环十二烷联盟行政核心和六溴环十二烷数据中心密切合作 协调中心制定全面的研究方案，并确保研究工作流程的合规性， 数据传输我们的联盟有一个优化的研究协议和4个具体目标：1）雇用道德和 以证据为基础的最佳实践，以招募和保留不同的孕妇队列， 婴儿/儿童大脑发育的研究，来自高风险背景的母亲和那些使用 （2）让一系列面向孕产妇和儿童的社区参与， 利益相关者确定社区对这项研究的关注和优先事项，最大限度地减少风险， 促进被招募的儿童-母亲二人组的长期参与; 3）收集丰富的数据，以研究如何 产妇健康状况和更广泛的环境因素可能会影响母胎二分体， 儿童神经发育; 4）捕捉关键的发展窗口，在此期间，母亲和 环境因素可能与儿童的大脑和行为发展相互作用。的见解 这些数据将使人们更好地了解影响幼儿大脑发育的因素， 允许有针对性的干预措施和改善母子二人组的结果。

PROJECT SUMMARY/ABSTRACT Brain development occurs at a rapid pace prenatally and throughout childhood, impacted by dynamic genetic and environmental influences. Studies using advanced neuroimaging have provided significant insights into brain development but have been limited by small sample size, especially for high-risk populations. Substance- exposed infants are at particularly high risk for adverse outcomes; however, findings are inconsistent, making it difficult to disentangle prenatal exposure effects from other adverse influences. The objectives of our HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) consortium are to characterize typical trajectories of brain development from birth through childhood, measuring the influence of key biologic and environmental factors and their interactions on child social, cognitive, and emotional development. We will assess how children prenatally exposed to opioids and other substances, as well as environmental adversity, differ in those brain trajectories and outcomes. Our consortium consists of six centers (Arkansas Children’s Research Institute, Case Western Reserve University, Cincinnati Children’s Hospital, Children’s National Medical Center, University of North Carolina at Chapel Hill, and Vanderbilt University) which have collaborated previously and have complementary expertise in neuroimaging, neurophysiology, longitudinal clinical research, child development, substance exposure and addiction, ethical/legal issues, and clinical care of high-risk infants/children. The PRELUDE consortium will recruit 680 pregnant women with substance use, 680 at-risk pregnant women without substance use, and 1360 comparison pregnant women representative of the general population to contribute to the overall HBCD study. We will work closely with the other sites, the HBCD Consortium Administrative Core, and the HBCD Data Coordinating Center to develop a comprehensive study protocol and ensure compliance of study workflow and data transfer. Our consortium has an optimized research protocol and 4 specific aims: 1) Employ ethical and evidence-based best practices to enroll and retain a diverse cohort of pregnant women into a longitudinal study of infant/child brain development, oversampling mothers from high-risk backgrounds and those using substances during pregnancy; 2) Engage a comprehensive array of maternal- and child-oriented community stakeholders to identify community concerns and priorities regarding this research, minimize risks, and promote long-term engagement of the recruited child-mother dyads; 3) Collect rich data to examine how maternal health context and broader environmental factors may affect the maternal-fetal dyad and neurodevelopment of children; 4) Capture key developmental windows during which maternal and environmental factors may interact with brain and behavioral development of children. The insights from these data will provide greater understanding of factors affecting early childhood brain development, allowing targeted interventions and improved outcomes for mother-child dyads.