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

基本信息

批准号：
10494299
负责人：
Karen M Grewen
金额：
$ 155.32万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
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/10494299
关键词：
Address Affect Age Alcohol consumption Arkansas Behavior assessment Behavioral Biological Biological Factors Birth Brain Child Child Development Childhood Clinical Research Cognitive Collection Communities Data Data Analyses Data Coordinating Center Development Electroencephalography Emotional Enrollment Ensure Environmental Risk Factor Ethics 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 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 data exchange design early childhood evidence base fetal high risk high risk infant high risk population improved improved outcome insight maternal stress neurodevelopment neuroimaging neurophysiology nutrition opioid misuse prenatal prenatal experience prenatal exposure racial and ethnic recruit resilience risk minimization social socioeconomic diversity stem substance use wearable device

项目摘要

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.

项目概要/摘要大脑发育在产前和整个童年时期都在快速发展，受到动态遗传的影响使用先进神经影像学的研究提供了重要的见解。大脑发育，但受到小样本量的限制，特别是对于高风险人群。接触过的婴儿出现不良后果的风险特别高；然而，研究结果并不一致，这使得很难将产前暴露影响与其他不利影响区分开来。大脑和儿童发育 (HBCD) 产前经历和纵向发展 (PRELUDE) 联盟将描绘从出生到童年的大脑发育的典型轨迹，衡量关键生物和环境因素及其相互作用对儿童社交的影响，我们将评估儿童在产前接触阿片类药物和其他药物的情况。物质以及环境逆境都会影响我们的大脑轨迹和结果。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、国家儿童医疗中心、北卡罗来纳大学教堂山分校，以及范德比尔特大学）之前曾合作过并在神经影像学方面拥有互补的专业知识，神经生理学、纵向临床研究、儿童发展、物质暴露和成瘾、 PRELUDE 联盟将招募 680 名研究人员，负责伦理/法律问题以及高危婴儿/儿童的临床护理。有药物滥用的孕妇、680 名没有药物使用的高危孕妇以及 1360 名代表一般人群的比较孕妇对总体六溴环十二烷研究做出了贡献。我们将与其他站点、HBCD 联盟管理核心和 HBCD 数据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和我们的联盟有一个优化的研究协议和 4 个具体目标：1）采用道德和基于证据的最佳实践，将不同的孕妇群体纳入纵向研究并保留对婴儿/儿童大脑发育的研究，对来自高风险背景的母亲和使用 2) 吸引一系列以母婴为导向的社区利益相关者确定社区对本研究的关注点和优先事项，最大限度地减少风险，以及促进招募的孩子与母亲的长期参与 3) 收集丰富的数据来研究如何进行；孕产妇健康状况和更广泛的环境因素可能会影响母婴二元关系， 4) 捕捉母亲和儿童的关键发育窗口环境因素可能与儿童的大脑和行为发展相互作用。这些数据将有助于更好地了解影响儿童早期大脑发育的因素，允许有针对性的干预措施并改善母子二人的结果。