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: 9900529
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9900529
• 关键词: Address; Affect; African American; Age; Area; Award; Behavioral; Brain; California; Child; Child Development; Childhood; Chronic; Collection; County; Data; Data Set; Development; Drug Exposure; Drug Prescriptions; Drug usage; Ensure; Ethics; Exposure to; Family; Feasibility Studies; 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; 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; 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; 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 pregnancy2-4. Drug use during pregnancy, both licit/prescription drugs and illicit substances, is on the rise7. Significant adverse developmental outcomes in prenatally-exposed children are documented beyond perinatal abnormalities9-11. 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 effects4. 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 nation15. 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 rise15. Prevalence rates are particularly high among individuals of childbearing age, and in already-vulnerable populations including African American females15,21. 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 neuroimaging8,22-25 and behavioral study13,19,20,26-30 of both normal5,8,12,19,25,26,31,32 and at-risk infants/children2,3,14,18,33 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.

项目总结 正在进行的全国范围的阿片类药物危机不仅给那些自己滥用药物的人带来了毁灭性的后果，而且 同样适用于怀孕期间接触阿片类药物的胎儿2-4。怀孕期间使用药物，包括合法/处方药和非法药物 物质，正在上升。记录了产前暴露儿童的严重不良发育结果 超越围产期异常9-11。然而，药物特有的长期效应仍然知之甚少，也知之甚少。 关于可能加剧或减轻其影响的潜在风险和复原力因素4。当前健康的大脑和儿童 发展(HBCD)RFA是解决这一关键研究差距的一项迫切需要和非常重要的努力。 2016年，加利福尼亚州有4654人死于药物过量，在全国排名第二。阿片类药物的流行率 2017年洛杉矶县(LA)的滥用比例为4.8%，高于4.5%的全国平均水平，而且仍在上升15。 在育龄人群和已经处于弱势的人群中，患病率尤其高。 包括15，21名非裔美国女性。总而言之，这些数据突显了对这些影响进行系统研究的迫切需要 在独特的社会人口洛杉矶县地区，产前药物暴露(PDE)的风险。我们团队在以下方面有丰富的经验 纵向神经成像8，22-25和行为研究13，19，20，26-30正常5，8，12，19，25，26，31，32和风险 婴儿/儿童2，3，14，18，33有不同的产前药物暴露。在这个项目中，我们的目标是利用这些经验和 确定洛杉矶地区大规模健康BCD第二阶段研究的可行性，具体目标有三个： (1)。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 (2)典型发育和高危婴儿/儿童的发育；建立一套高度可执行的 无毒品和有毒品接触的婴儿/儿童的招募和保留战略；以及(3)建立 将有助于实现第二阶段研究的三个关键研究目标的综合研究方案。这 该项目意义重大，因为它预计将为我们的洛杉矶团队和站点做好准备，以便在全国范围内参与 健康的BCD研究，以便在独特的社会人口统计洛杉矶地区的高危孕妇和儿童可以 具有代表性，并可能从这项重要研究中受益。它的创新性在于：1)我们的分布式网络 涵盖不同人群的招聘地点，包括特权家庭和资源匮乏的家庭，将提供 研究与PDE相关的社会经济风险和复原力因素的独特机会；和2)我们经验丰富的团队将 制定创新的招聘/保留战略和研究方案，以更好地为第二阶段健康的BCD做准备 学习。它与公共卫生相关，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-在全国人口最多和 受影响最严重的地区-洛杉矶县地区。