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

• 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
• 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

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 早期生活压力（ELS）基础和临床研究表明，这些不同的暴露， 单独或组合，可以破坏大脑结构和功能的早期发育轨迹， 对孩子的健康有长期的危害。洛杉矶儿童医院的R34 HEAL计划拨款申请 （CHLA）/南加州大学（USC）将是至关重要的财团假设产生的第二阶段， 为了解开复杂的环境因素如何影响大脑发育和功能-从胎儿 通过第一个十年的时间-塑造认知，社会和情感的发展。的危险因素 由诊所，CHLA，好莱坞长老会医院和Altamed社区的校园服务的家庭 医疗中心，在加州是无与伦比的。在被招募的家庭中，>75%的家庭接受医疗补助， 50%低于联邦贫困线，任何种族的西班牙裔/拉丁裔都很富裕。USC-CHLA 由调查员和双语及多文化研究人员组成的团队在招聘方面具有深厚的专业知识 在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、发展心理学和行为儿科学以及生物测量学。以确保最大 保护弱势群体和有效的招募和保留，该小组包括一个世界- 社会/法律的和医学伦理方面的知名专家，以补充我们的经验和社区伙伴关系。 对于HEAL I期，将招募两个队列以满足年龄范围目标。队列1将纳入40例妊娠 妇女及其胎儿/婴儿，以测试不同研究访视时间表对数据质量的可行性和效用 的主体负担。队列2将包括从我们正在进行的两项研究之一招募的10对母婴配对。 纵向研究调查早期生活压力对发育的影响。将解决三个具体目标 HEAL RFA的既定目标：目标1）制定战略，招募和保留一个种族和族裔 孕妇（及其胎儿）的不同样本，因不利环境风险而被过度采样 目标2）制定战略，管理潜在的法律的和 确保母子二人组获得法律的、社会和心理支持方面的道德挑战 根据需要提供服务;目标3）为计划的II期研究确定最佳研究方案-平衡 需要收集高质量的纵向数据，同时需要尽量减少母子二人组的负担。 多学科的方法包括胎儿，婴儿和幼儿MRI，高分辨率脑电图 和眼动追踪，有希望的生物样本（儿童口腔拭子，尿液和血滴;母亲母乳，血液和 头发）、人口统计学、身心健康、对母子二人组的社会支持以及行为- 儿童的认知测量。从征聘、留用和数据收集中吸取的经验教训将得到充分的 为了形成第二阶段HEAL计划的最佳假设和研究设计而共享。