Biological and Environmental Contributions to Healthy Baby Development in Diverse Population

生物和环境对不同人群婴儿健康发育的贡献

基本信息

批准号：
9900560
负责人：
PAT LEVITT
金额：
$ 28.6万
依托单位：
CHILDREN'S HOSPITAL OF LOS ANGELES
依托单位国家：
美国
项目类别：
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/9900560
关键词：
Address Adverse event Age Alcohols Ambulatory Care Facilities Applications Grants Basic Science Behavioral Biological Birth Rate Blood Brain California Cannabis Child Child Development Childhood Clinic Clinical Research Cognitive Communities Complement Complex County Cultural Diversity Data Collection Data Quality Development Drops Drug Exposure Electroencephalography Emotional Ensure Environmental Risk Factor Epidemiology Equilibrium Ethics Exposure to Eye Family Fetal Alcohol Exposure Fetal Development Fetus Generations Goals Grant Hair Health Hispanics Hospitals Human Milk Income Individual Infant Inpatients Legal Life Longitudinal Studies Los Angeles Magnetic Resonance Imaging Measurement Measures Medicaid Medical Ethics Medical center Mental Health Methodology Methods Modeling Mothers Motor Activity Neonatal Abstinence Syndrome Only Child Outcome Pediatric Hospitals Pediatrics Phase Physiological Physiology Population Population Heterogeneity Poverty Pregnancy Pregnant Women Presbyterian Church Prevention program Protocols documentation Questionnaires Race Reporting Research Research Design Research Personnel Resolution Resources Risk Risk Factors Saliva Sampling Schedule Services Shapes Site Social support Spottings Stress Structure Substance of Abuse Swab Testing Time Toddler Universities Urine Visit Vulnerable Populations bilingualism cohort community clinic community partnership design developmental psychology drug of abuse early experience early life adversity early life stress ethnic diversity experience falls federal poverty level fetal fetal drug exposure fetal opioid exposure high risk high risk population interdisciplinary approach longitudinal design member metabolomics multidisciplinary multimodality neurodevelopment neuroimaging neurophysiology novel nutrition pediatric patients phase 2 designs phase 2 study physical conditioning postnatal primary caregiver psychologic psychosocial racial diversity recruit resilience safety net social study population treatment program ward wearable device

项目摘要

Children exposed during pregnancy to substances of abuse are also at high-risk for other environmental factors associated with early life stress (ELS). Basic and clinical research shows that these various exposures, individually or in combination, can disrupt early developmental trajectories of brain structure and function and enduring health risk for the child. This R34 HEAL planning grant application from Children’s Hospital Los Angeles (CHLA)/University of Southern California (USC) will be vital for consortium hypothesis generation in Phase II in order to disentangle how complex environmental factors impact brain development and function - from fetal period through the first decade - to shape cognitive, social and emotional development. The risk factors for families served by this campus of clinics, CHLA, Hollywood Presbyterian Hospital and Altamed Community Medical Center, is unparalleled in California. Of the families to be recruited, >75% are on Medicaid, more than 50% are below the federal poverty level, and there is enrichment of Hispanic/Latinx of any race. The USC-CHLA team of investigators and bilingual and multi-cultural research staff bring a depth of expertise in recruitment during pregnancy and early postnatal, as well as experimental expertise in epidemiology, neuroimaging, neurophysiology, developmental psychology and behavioral pediatrics, and biomeasures. To ensure maximum protection of a vulnerable population and effective recruitment and retention, the team includes a world- renowned expert in social/legal and medical ethics to complement our experience and community partnerships. For HEAL Phase I, two cohorts will be recruited to meet age range goals. Cohort 1 will include 40 pregnant women and their fetuses/infants to test the feasibility and utility of different study visit schedules on data quality and subject burden. Cohort 2 will include 10 mother-toddler dyads recruited from one of our two ongoing longitudinal studies investigating the impact of early life stress on development. Three specific aims will address the stated goals of the HEAL RFA: Aim 1) to develop the strategies to recruit and retain a racially- and ethnically diverse sample of pregnant women (and their fetuses), who are oversampled for adverse environmental risk factors and exposure to substances of abuse; Aim 2) to develop the strategies for managing potential legal and ethical challenges to ensure that the mother-child dyads have access to legal, social and psychological support services as needed; Aim 3) to determine the optimal study protocol for the planned, phase II study – balancing the need for high quality, longitudinal data collection with the need to minimize burden on the mother-child dyads. The multidisciplinary approaches include fetal, infant and toddler MRI, high-resolution electroencephalography and eye-tracking, promising biosamples (child buccal swab, urine and blood drops; mother breastmilk, blood and hair), and demographic, physical and mental health, social support for mother/child dyads, and behavioral- cognitive measures in children. Lessons learned from recruitment, retention and data collection will be fully shared in order to form best hypotheses and research designs for the Phase II HEAL initiative.

怀孕期间接触滥用物质的儿童也面临其他环境因素的高风险与早期生活压力（ELS）相关基础和临床研究表明，这些不同的暴露，单独或组合，可以扰乱大脑结构和功能的早期发育轨迹，儿童面临持久的健康风险。来自洛杉矶儿童医院的 R34 HEAL 计划拨款申请。 (CHLA)/南加州大学 (USC) 对于第二阶段的联合假设生成至关重要为了弄清楚复杂的环境因素如何影响胎儿的大脑发育和功能第一个十年 - 塑造认知、社交和情感发展的风险因素。该诊所、CHLA、好莱坞长老会医院和阿尔塔梅德社区所服务的家庭医疗中心，这在加州是无与伦比的。在被招募的家庭中，>75% 享受医疗补助，超过 75%。 50% 的人口低于联邦贫困线，而且任何种族的西班牙裔/拉丁裔都有丰富的人口。由调查员和双语和多文化研究人员组成的团队在招聘方面带来了深厚的专业知识怀孕期间和产后早期，以及流行病学、神经影像学、神经生理学、发育心理学和行为儿科以及生物测量学以确保最大程度的发挥。保护弱势群体并有效招募和保留，该团队包括来自世界各地的社会/法律和医学道德领域的知名专家补充了我们的经验和社区合作伙伴关系。对于 HEAL 第一阶段，将招募两个队列来满足年龄范围目标，队列 1 将包括 40 名孕妇。妇女及其胎儿/婴儿测试不同研究访问计划在数据质量方面的可行性和实用性第 2 组将包括从我们两个正在进行的其中之一招募的 10 名母婴二人组。调查早期生活压力对发展的影响的纵向研究将解决三个具体目标。 HEAL RFA 的既定目标：目标 1) 制定招募和保留种族和民族群体的策略孕妇（及其胎儿）的多样化样本，因不利环境风险而被过度采样目标 2) 制定管理潜在法律和滥用物质的策略；确保母子二人获得法律、社会和心理支持的道德挑战根据需要提供服务；目标 3) 确定计划的第二阶段研究的最佳研究方案 – 平衡需要收集高质量的纵向数据，并需要最大限度地减少母子二人的负担。多学科方法包括胎儿、婴儿和幼儿 MRI、高分辨率脑电图眼动追踪、有前景的生物样本（儿童口腔拭子、尿液和血滴；母亲母乳、血液和头发），以及人口、身心健康、对母子二人组的社会支持以及行为- 从招募、保留和数据收集中吸取的经验教训将得到充分利用。以便为第二阶段 HEAL 计划形成最佳假设和研究设计。