Planning Phase for the Healthy Brain and Child Development Study (HEALthy BCD) in Los Angeles County Area

洛杉矶县地区健康大脑和儿童发展研究 (HEALthy BCD) 的规划阶段

• 批准号: 10017557
• 负责人: Wei Gao
• 金额: $ 29.35万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 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 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017557
• 关键词: Address; Affect; African American; Age; Area; Award; Behavioral; Brain; California; Child; Child Development; Childhood; Chronic; Cocaine; Collection; County; Data; Data Set; Development; Drug Exposure; Drug Prescriptions; Drug usage; Ensure; Ethics; Exposure to; Family; Feasibility Studies; Female; Fetal Cocaine Exposure; Fetus; Focus Groups; Frequencies; Funding; Goals; Grant; Hospitals; Iatrogenesis; Incentives; Individual; Infant; Infrastructure; Knowledge; Lead; Legal; Long-Term Effects; Los Angeles; Magnetic Resonance Imaging; Marijuana; Medical center; Neonatal Abstinence Syndrome; Opioid; Outcome; Perinatal; Pharmaceutical Preparations; Phase; Physicians; Population; Postpartum Women; Precision Health; Pregnancy; Pregnant Women; Prevalence; Protocols documentation; Psychologist; Public Health; Research; Research Personnel; Resources; Risk; Sample Size; Sampling; Silver; Site; Structure; Substance Use Disorder; Testing; Time; Vulnerable Populations; Woman; Work; antenatal; base; behavioral study; child bearing; design; experience; fetal drug exposure; high risk; in utero; innovation; member; neonatal exposure; neonate; neuroimaging; next generation; opioid epidemic; opioid exposure; opioid misuse; opioid use in pregnancy; overdose death; phase 2 study; prenatal exposure; psychologic; recruit; resilience; retention rate; social; sociodemographics; socioeconomics; treatment center

PROJECT SUMMARY The ongoing nation-wide opioid crisis incurs devastating consequences not only for those who abuse drugs themselves but also for fetuses exposed to opioids during pregnancy. Drug use during pregnancy, both licit/prescription drugs and illicit substances, is on the rise. Significant adverse developmental outcomes in prenatally-exposed children are documented beyond perinatal abnormalities. However, drug-specific long-term effects remain poorly understood and little is known about potential risk and resilience factors that may exacerbate or mitigate their effects. The current Healthy Brain and Child Development (HBCD) RFA represents an urgently needed and highly important effort to tackle this critical research gap. In 2016, California had 4654 drug overdose deaths, the 2nd highest number in the nation. The prevalence rate of opioids misuse in the Los Angeles county (LA) in 2017 is 4.8%, higher than the national average of 4.5%, and is still on the rise. Prevalence rates are particularly high among individuals of childbearing age, and in already-vulnerable populations including African American females. Together, these data highlight a pressing need for a systematic study of the effects of prenatal drug exposures (PDE) in the unique sociodemographic LA county area. Our team has extensive experience in longitudinal neuroimaging and behavioral study of both normal and at-risk infants/children with different prenatal drug exposures. In this project, we aim to leverage these experiences and establish the feasibility for the large-scale Phase II HEALthy BCD study in the Los Angeles area with three specific aims: (1). To build a broad interdisciplinary team of investigators capable of a multi-faceted study of brain and behavioral development in both typically developing and at-risk infants/children; (2). To establish a set of highly executable recruitment and retention strategies for both drug-free and drug-exposed infants/children; and (3). To establish comprehensive study protocols that will help address the three key research objectives of the Phase II study. This project is significant because it is expected to prepare our LA team and sites to be ready to participate in the nation-wide HEALthy BCD study so that the at-risk pregnant women and children in the unique sociodemographic LA area can be represented and potentially benefit from this important study. It is innovative because: 1) our distributed network of recruitment sites covering divergent populations including both privileged and resource-deprived families will provide a unique opportunity to study socioeconomic-related risk and resilience factors on PDE; and 2) our experienced team will develop innovative recruitment/retention strategies and study protocols to better prepare for the Phase II HEALthy BCD study. It is relevant to public health because it represents the start to better understand and potentially address one of the most devastating problems affecting our next generation-prenatal drug exposure in one of the nation’s most populated and most affected areas-the Los Angeles County area.

项目摘要 正在进行的全国性阿片类药物危机不仅对那些滥用药物的人造成了破坏性后果， 也适用于妊娠期间暴露于阿片类药物的胎儿。怀孕期间使用合法/处方药和非法药物 物质，正在上升。记录了产前暴露儿童的显著不良发育结果 除了围产期的异常然而，药物特异性的长期影响仍然知之甚少，知之甚少 关于可能加剧或减轻其影响的潜在风险和复原力因素。健康的大脑和儿童 针对六溴环十二烷的RFA是解决这一关键研究缺口的一项迫切需要且非常重要的工作。 2016年，加州有4654例药物过量死亡，是全国第二高的数字。阿片类药物流行率 2017年洛杉矶县（LA）的滥用率为4.8%，高于全国平均水平4.5%，并且仍在上升。 在育龄人群和已经脆弱的人群中， 包括非裔美国女性总之，这些数据突出了对影响进行系统研究的迫切需要 产前药物暴露（PDE）在独特的社会人口洛杉矶县地区。我们的团队拥有丰富的经验， 正常和高危人群的纵向神经影像学和行为学研究 不同产前药物暴露的婴儿/儿童。在这个项目中，我们的目标是利用这些经验， 确定在洛杉矶地区开展大规模II期HEALthy BCD研究的可行性，该研究有三个具体目标： （一）.建立一支广泛的跨学科研究团队，能够对大脑和行为进行多方面的研究， 典型发育和高危婴儿/儿童的发育;（2）.建立一套可执行性强的 为未接触毒品和接触毒品的婴儿/儿童制定招募和保留策略;以及（3）.建立 全面的研究方案，这将有助于解决第二阶段研究的三个关键研究目标。这 该项目意义重大，因为它预计将准备我们的洛杉矶团队和网站准备参加全国范围内的 HEALthy BCD研究，以便在独特的社会人口LA地区的高危孕妇和儿童可以 并可能从这项重要的研究中受益。它是创新的，因为：1）我们的分布式网络 招募地点涵盖不同的人口，包括特权和资源匮乏的家庭，将提供一个 研究PDE的社会经济相关风险和弹性因素的独特机会; 2）我们经验丰富的团队将 制定创新的招募/保留策略和研究方案，以更好地为II期健康BCD做准备 study.它与公共卫生有关，因为它代表着更好地理解和潜在地解决 影响我们下一代的最具破坏性的问题-产前药物暴露在全国人口最多， 受影响最严重的地区--洛杉矶县。