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: 9898784
• 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/9898784
• 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.

但是，怀孕期间的使用和育儿可以对发育产生深远的影响。 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 寻求创建一个全国性怀孕队列，即“健康的BCD”，跟随孕妇及其后代 暴露并暴露于10岁之前。巴尔的摩的使用率很高，患病率很高 儿童健康状况不佳的其他危险因素，例如暴露于暴力，有毒物质，毛孔住房和 歧视。这些事实使巴尔的摩成为健康BCD的重要网站 独立性和药物使用和侵略性因素在儿童健康中的作用。 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） 以及所需较高元素的各种专业知识：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，孕产妇和儿童健康服务，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，不利的童年经验， 定性方法以及流行病学和统计工具。 阶段请求，我们将在Jhu举行的“果园”（儿童的起源）扩大接待处，妊娠队列（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。 还将确定和计划解决道德和法律挑战的解决方案。 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 保留孕妇的母亲和儿童丰富了使用的孕妇 物质（2）建立暗示所需的社区，医疗和政府伙伴关系 招聘，保留，数据创造和社区福利（3s）是批判性道德和法律的特征 在设计期间，试点研究和潜在参与者的挑战，并提出解决方案 （4）制定纵向数据的协议。 跨怀孕和童年的收集以测量a）怀孕和早期孕产妇和儿童 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 Connection MRI上建立。 协议和其他扫描有关大脑发育的更多信息，特别是针对的 神秘性在很早的生活中变化，d）计划时机和类型的生物样本，e） 数据科学支持（5）有助于多站点协议开发和国家列出原则 关于道德和法律问题。