5/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium

5/6 六溴环十二烷产前经历和纵向发展 (PRELUDE) 联盟

• 批准号: 10661752
• 负责人: Stephanie Engel
• 金额: $ 199.82万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10661752
• 关键词: Address; Affect; Age; Alcohol consumption; Arkansas; Behavior assessment; Behavioral; Biological; Biological Factors; Birth; Brain; Child; Child Development; Childhood; Clinical Research; Cognitive; Collaborations; Collection; Communities; Data; Data Analyses; Data Coordinating Center; Dedications; Development; Electroencephalography; Emotional; Enrollment; Ensure; Environmental Risk Factor; Ethics; Ethnic Origin; Exposure to; Family; Funding; General Population; Genetic; Geography; Goals; Helping to End Addiction Long-term; Home environment; Image; Infant; Institution; Intervention; Legal; Longitudinal Studies; Magnetic Resonance Imaging; Maternal Health; Maternal and Child Health; Measures; Medical center; Mental Health; Mothers; North Carolina; Opiate Addiction; Opioid; Outcome; Parent-Child Relations; Parents; Participant; Pediatric Hospitals; Phase; Physiological; Poverty; Pregnancy; Pregnant Women; Prenatal care; Protocols documentation; Public Health; Questionnaires; Race; Research; Research Institute; Resources; Risk; Risk Factors; Sample Size; Sampling; School-Age Population; Second Pregnancy Trimester; Series; Site; Speed; Third Pregnancy Trimester; Tobacco; Toxic Environmental Substances; United States National Institutes of Health; Universities; Visit; Work; addiction; adverse outcome; clinical care; cohort; community engagement; data exchange; design; early childhood; evidence base; fetal; high risk; high risk infant; high risk population; improved; improved outcome; insight; maternal outcome; maternal stress; neurodevelopment; neuroimaging; neurophysiology; nutrition; opioid misuse; post pregnancy; prenatal; prenatal experience; prenatal exposure; recruit; resilience; risk minimization; social; socioeconomic diversity; stem; substance use; wearable device

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.

项目摘要/摘要 大脑发育发生在产前和整个童年时期，受动态遗传的影响 和环境影响。使用高级神经影像学的研究为 大脑发育，但受到小样本量的限制，尤其是对于高风险人群。物质- 暴露的婴儿尤其有不良后果的风险；但是，发现不一致，使得 难以从其他不良影响中解散产前暴露的影响。我们健康的目标 大脑和儿童发育（HBCD）产前经验和纵向发展（Prelude） 财团将表征从出生到儿童时期的典型脑发育轨迹， 衡量关键生物学和环境因素的影响及其对儿童社会的相互作用， 认知和情感发展。我们将评估儿童在产前如何接触阿片类药物和其他 这些脑轨迹和结果在这些物质以及环境逆境中都不同。我们的财团 由六个中心组成（辛辛那提凯斯西部储备大学阿肯色州儿童研究所 儿童医院，儿童国家医学中心，北卡罗来纳大学教堂山分校， 范德比尔特大学（Vanderbilt University） 神经生理学，纵向临床研究，儿童发育，物质暴露和成瘾， 道德/法律问题，以及高危婴儿/儿童的临床护理。序列联盟将招募680 有药物使用的孕妇，680名不使用药物的高危孕妇，1360 比较代表普通人群的孕妇有助于总体HBCD研究。 我们将与其他站点，HBCD联盟管理核心和HBCD数据紧密合作 协调中心制定全面的研究方案，并确保遵守研究工作流程和 数据传输。我们的财团具有优化的研究方案，4个具体目的：1）雇用道德和 基于证据的最佳实践，以注册和保留一群孕妇的潜水员队伍进入纵向 研究婴儿/儿童脑发育，高风险背景的过度采样母亲以及使用的母亲 怀孕期间的物质； 2）参与一系列孕产妇和面向儿童的社区 利益相关者确定社区对这项研究的关注和优先事项，最大程度地降低风险以及 促进招募的子女二元组的长期参与； 3）收集丰富的数据以检查如何 孕产妇的健康环境和更广泛的环境因素可能会影响母亲的二元组和 儿童神经发育； 4）捕获关键的发育窗口，在此窗口和 环境因素可能与大脑和儿童行为发展相互作用。来自的见解 这些数据将对影响儿童脑发育的因素有更深入的了解， 允许有针对性的干预措施，并改善了母子二元组的结果。