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

怀孕期间和养育子女期间使用药物会对发育产生深远的影响。然而，在这方面， 随着时间的推移，这些后果很少在同一母亲和婴儿身上直接测量。国家卫生研究院 旨在建立一个全国性的怀孕队列，“健康BCD”，将跟踪孕妇及其后代， 在10岁之前暴露和不暴露于物质。巴尔的摩的阿片类药物使用率高， 儿童健康状况不佳的其他风险因素，如接触暴力、毒物、住房条件差， 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 药物使用和其他环境和社会因素对儿童健康的独立和相互作用。 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）有广泛的 和各种专业知识，涵盖所需的每一个基本要素：阿片类药物和其他物质，纵向 妊娠队列，神经发育评估，神经影像学，妇幼保健服务，伦理 和法律的问题，基因组学和表观基因组学，社会和行为科学，不良的童年经历， 定性方法以及流行病学和统计工具。针对目前18个月的规划 阶段的要求，我们将扩大最近在JHU启动的怀孕队列称为果园（儿童起源 健康和发展的弹性），以创建一个巴尔的摩健康的BCD网站，命名为健康果园。 我们将发展必要的关键伙伴关系和协议，以创建，建立和管理这一群体。我们 还将确定和计划解决道德和法律的挑战。我们的活动将召集JHU/KKI 9个工作组的调查员和社区合作伙伴，以（1）制定征聘议定书 对正在使用避孕药具的孕妇进行丰富的抽样， （2）建立必要的社区、医疗和政府伙伴关系， 招聘、保留、数据收集和社区福利（3s）描述关键的道德和法律的 研究设计、试点研究和潜在参与者提出的挑战，并提出解决方案 在可能的情况下，并在必要时进行额外的研究。(4)制定纵向数据协议 a）怀孕和生命早期的孕产妇和儿童 物质使用暴露以及其他社会、环境和基因组风险因素，B）母体和 从出生到10岁的儿童健康和神经发育结果，c）纵向神经成像， 包括试点扫描和分析，我们将建立在青少年（ABCD）和婴儿连接体MRI的基础上， 协议，并增加额外的扫描，以获得更多关于大脑发育的信息，特别是针对 髓鞘形成在生命早期的变化，d）计划收集生物样品的时间和类型，e）开发 数据科学支持（5）促进多站点协议开发和国家相关原则 关于道德和法律的问题。

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.