HEALthy ORCHARD: Developing plans for a Baltimore site of the HEALthy BCD study

健康果园：为健康 BCD 研究巴尔的摩地点制定计划

• 批准号: 10021754
• 负责人: M Daniele Fallin
• 金额: $ 28.36万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021754
• 关键词: Adolescent; Age; Alcohol or Other Drugs use; Baltimore; Behavioral Sciences; Biogenesis; Biological; Biological Markers; Birth; Brain; Categories; Child; Child Health; Child Rearing; Childhood; Cities; Communities; Data; Data Analyses; Data Collection; Data Science; Data Storage and Retrieval; Development; Diagnostic; Discrimination; Disease; Elements; Emotional; Environmental Engineering technology; Environmental Health; Epidemiology; Ethics; Family; Funding; Genomics; Goals; Government; High Prevalence; Housing; Infrastructure; Institutes; Joints; Legal; Life; Magnetic Resonance Imaging; Maryland; Maternal and Child Health; Maternal-Child Health Services; Measures; Medical; Mental Health; Mothers; Names; Opioid; Outcome; Participant; Pediatrics; Personal Satisfaction; Pharmaceutical Preparations; Phase; Pilot Projects; Play; Policies; Pregnancy; Pregnant Women; Prevalence; Prevention strategy; Protocols documentation; Qualitative Methods; Qualitative Research; Research; Research Design; Research Personnel; Risk Factors; Role; Sampling; Scanning; Site; Social Sciences; Source; Substance Use Disorder; Time; United States National Institutes of Health; Universities; adverse childhood events; cognitive development; cohort; connectome; design; disability; epigenomics; experience; family support; member; mortality; myelination; neuroimaging; offspring; opioid mortality; opioid use; overdose death; prevent; prospective; protocol development; psychosocial; recruit; repository; resilience; response; retention rate; social; tool; toxicant; treatment strategy; violence exposure; working group

Substance use during pregnancy and while parenting can have profound effects on development. However, these consequences have rarely been directly measured in the same mothers and babies over time. The NIH seeks to create a national pregnancy cohort, “HEALthy BCD,” that will follow pregnant women and their offspring exposed and unexposed to substances until age 10. Baltimore has high rates of opioid use and high prevalence of other risk factors for poor child health outcomes such as exposure to violence, toxicants, poor housing, and discrimination. These facts make Baltimore an important site for HEALthy BCD to help understand the independent and interacting roles of substance use and other environmental and social factors on child health. Johns Hopkins University (JHU) and our pediatric partner, the Kennedy Krieger Institute (KKI) have extensive and diverse expertise across every essential element required: opioids and other substances, longitudinal pregnancy cohorts, neurodevelopmental assessments, neuroimaging, maternal and child health services, ethical and legal issues, genomics and epigenomics, social and behavioral sciences, adverse childhood experiences, qualitative methods, and epidemiological and statistical tools. In response to the current 18-month planning phase request, we will expand a recently initiated pregnancy cohort at JHU called ORCHARD (ORigins of Child Health And Resilience in Development) to create a Baltimore HEALthy BCD site, named HEALthy ORCHARD. We will develop the critical partnerships and protocols necessary to create, build, and steward this cohort. We will also identify and plan solutions for ethical and legal challenges. Our activities will convene JHU/KKI investigators and community partners across nine work groups to (1) Develop protocols for recruitment and retention of pregnant mothers and children with enriched sampling of pregnant women who are using substances (2) Establish community, medical, and government partnerships necessary to implement recruitment, retention, data collection and community benefits (3s) Characterize the critical ethical and legal challenges raised during study design, in pilot studies, and by prospective participants, and propose solutions where possible, and additional research where necessary. (4) Develop protocols for longitudinal data collection across pregnancy and childhood to measure a) Pregnancy and early life maternal and child substance use exposures as well as other social, environmental, and genomic risk factors, b) Maternal and child health and neurodevelopmental outcomes from birth to age 10, c) Longitudinal neuroimaging, including pilot scans and analyses, where we will build upon the adolescent (ABCD) and baby connectome MRI protocols and add additional scans for more information regarding brain development, especially geared towards myelination changes in very early life, d) plan timing and types of biosamples to be collected, e) develop data science supports (5) Contribute to multi-site protocol development and nationally-relevant principles regarding ethical and legal issues.

怀孕期间和育儿期间的药物使用会对发育产生深远的影响。然而， 随着时间的流逝，这些后果很少直接在同一母亲和婴儿中进行测量。 NIH 寻求创建一个全国性怀孕队列“健康BCD”，该队列将跟随孕妇及其后代 直到10岁才暴露并出乎意料。巴尔的摩的阿片类药物使用率很高和高患病率 儿童健康状况不佳的其他风险因素，例如暴露于暴力，有毒物质，住房不良和 歧视。这些事实使巴尔的摩成为健康BCD的重要网站，以帮助了解 物质使用以及其他环境和社会因素在儿童健康中的独立和相互作用的作用。 约翰·霍普金斯大学（JHU）和我们的儿科合作伙伴肯尼迪·克里格研究所（KKI） 以及所需的每个基本要素的潜水员专业知识：阿片类药物和其他物质，纵向 怀孕队列，神经发育评估，神经影像学，母亲和儿童健康服务，道德 以及法律问题，基因组学和表观基因组学，社会和行为科学，不利的童年经历， 定性方法以及流行病学和统计工具。回应当前的18个月计划 阶段请求，我们将扩大最近在Jhu的妊娠队列的果园（儿童的起源） 在开发中的健康和韧性）创建一个巴尔的摩健康的BCD网站，名为Healthy Orchard。 我们将开发创建，建立和管理此队列所需的重要合作伙伴关系和协议。我们 还将确定并计划解决道德和法律挑战的解决方案。我们的活动将召集jhu/kki 跨九个工作组的调查人员和社区合作伙伴（1）制定招聘协议 并保留使用孕妇的孕妇和儿童的使用 物质（2）建立实施社区，医疗和政府伙伴关系 招聘，保留，数据收集和社区福利（3s）是批判性道德和法律的特征 在研究设计，试点研究和准参与者中提出的挑战以及建议解决方案 在可能的情况下，以及必要的其他研究。 （4）制定纵向数据的协议 跨怀孕和童年的收集以测量a）怀孕和早期生命和儿童 药物使用暴露以及其他社会，环境和基因组危险因素，b）孕产妇和 从出生到10岁的儿童健康和神经发育结果，c）纵向神经影像学， 包括飞行员扫描和分析，我们将在青少年（ABCD）和Baby Connectome MRI上建立。 协议并添加其他扫描，以获取有关大脑发育的更多信息，尤其是针对 髓鞘变化在很早的生活中，d）计划的时间和要收集的生物样本的类型，e） 数据科学支持（5）有助于多站点协议开发和与国家相关的原则 关心的道德和法律问题。