3 of 4, Investigation of opioid exposure and neurodevelopment (iOPEN)

3 of 4，阿片类药物暴露和神经发育的调查 (iOPEN)

• 批准号: 10020453
• 负责人: HUGH P. GARAVAN
• 金额: $ 26.33万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 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/10020453
• 关键词: 2 year old; Acceleration; Address; Affect; Age; Alcohol or Other Drugs use; Assessment tool; Attitude; Biological; Birth; Brain; Brain imaging; Centers for Disease Control and Prevention (U.S.); Characteristics; Child; Child Development; Childhood; Collection; Communities; Data; Data Collection; Data Quality; Data Set; Development; Disadvantaged; Dropout; Drops; Elements; Enrollment; Environmental Risk Factor; Ethics; Exposure to; Family; Fathers; Fetal Development; Fetus; Foundations; Health Sciences; Image; Image Analysis; Infant; Institutes; Institutional Review Boards; Investigation; Knowledge; Learning; Legal; Link; Logistics; Long-Term Effects; Longitudinal Studies; Longitudinal Surveys; Longitudinal cohort study; Longitudinal prospective study; Magnetic Resonance Imaging; Measurement; Measures; Medical center; Meta-Analysis; Methodology; Methods; Modeling; Monitor; Mothers; Motion; Movement; Neonatal; Neonatal Abstinence Syndrome; New York; Opioid; Opioid user; Oregon; Outcome; Participant; Personal Satisfaction; Persons; Phase; Placenta; Population; Positioning Attribute; Pregnancy; Pregnant Women; Probability; Prospective cohort study; Protocols documentation; Psychosocial Assessment and Care; Recording of previous events; Research; Research Design; Research Personnel; Resources; Risk Factors; Role; Rural; Sampling; Savings; Site; Standardization; Testing; Third Pregnancy Trimester; Time; Toddler; United States National Institutes of Health; Universities; Validation; Variant; Vermont; Woman; Work; base; biobehavior; child protective service; computerized data processing; data acquisition; data collection methodology; data sharing; data structure; demographics; design; early childhood; efficacy testing; experience; fetal; fetal drug exposure; fetal opioid exposure; flexibility; health assessment; high risk; high risk population; improved; incentive strategies; innovation; lifestyle factors; multidisciplinary; multimodality; neonatal magnetic resonance imaging; neonate; neurodevelopment; neuroimaging; novel; open source; opioid epidemic; opioid exposure; opioid use; opioid use disorder; opioid use in pregnancy; phase 2 study; postnatal; preference; pregnant; prenatal exposure; prospective; recruit; response; retention rate; success; tool; usability; young mother

PROJECT SUMMARY ABSTRACT Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide and, according to the CDC, Vermont, at 48.6 per 1,000, has the highest rate of women with opioid use disorder at delivery in the US. This situation creates an urgent need to identify how in utero exposure to opioids and associated risk factors influence the developing brain. Rigorous scientific investigation of this topic requires addressing the lack of foundational knowledge of neurotypical development. In addition, because postnatal brain development is modified by environmental experiences, it will be important to tease apart effects of prental opioid exposure from lifestyle factors associated with opioid use. This proposal brings together a multidisciplinary team with the expertise, experience, and institutional support to address these challenges in Vermont, a rural state hit particularly hard by the opioid epidemic. Through linking with three other sites, Oregon Health and Sciences University, New York University, and University of Pittsburgh Medical Center, the impact of this project is significantly enhanced. The activities in thie Phase I application will provide critical information to support a national level effort for Phase II of the HEALthy Brain and Child Development Study. In Specific Aim 1, we develop, implement and evaluate innovative recruitment and retention strategies for high- risk populations. This includes measuring the feasibility, throughput, and demographic characteristics associated with different recruitment methods through a longitudinal survey of 150 pregnant women per site (n=600 across sites), half of whom use opioids during pregnancy. Specific Aim 2 addresses anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized, research protocol including multimodal MRI of placenta, fetus, neonate and 24-month-old brain, biospecimen collection, and asessment of substance use, and other key domains. Feasibility, data quality, and efficacy of different assessment methods will be evaluated in a longitudinal sample of 20 mother-infant dyads (N=80 across sites, half of whom use opioids during pregnancy), and a cross-sectional sample of five 24-month-old children with a history of prenatal opioid exposure (N=20 across sites). Specific Aim 3 evaluates data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites. In this aim we examine the efficacy of real-time motion monitoring for improving MRI data quality at different developmental stages; test novel MRI acceleration protocols; and harmonize data and processing pipelines for fetal, neonatal and child MRI into an open-source framework based on the universal Brain Imaging Data Structure (BIDS) and BIDS application routines. This project draws upon the investigators' foundational experience recruiting and retaining substance using pregnant women (MOTHER study; ECHO), working with our Vermont legal and ethical partners (i.e. IRB, Child Protective Services, etc.), and in collaborating in large muti-site neurodevelopmental studies (ABCD).

项目总结摘要 新生儿禁欲综合症的发生率在全国范围内达到了令人震惊的每1000名新生儿中有6.5人， 根据美国疾病控制与预防中心的数据，佛蒙特州的阿片类药物使用障碍女性比例最高，为每1000人中有48.6人 在美国送货。这种情况迫切需要确定在子宫内如何接触阿片类药物和 相关的风险因素会影响发育中的大脑。对这一主题进行严格的科学调查需要 解决缺乏神经典型发育的基础知识的问题。另外，因为出生后 大脑发育受环境经验的影响，重要的是梳理出 与阿片类药物使用相关的生活方式因素导致的前期阿片类药物暴露。这项建议汇集了一个 拥有专业知识、经验和机构支持的多学科团队，可应对这些挑战 佛蒙特州，一个受阿片类药物流行打击特别严重的农村州。通过与其他三个网站的链接， 俄勒冈健康与科学大学、纽约大学和匹兹堡大学医学中心 这一项目的影响显著增强。此阶段应用程序中的活动将提供关键的 信息，以支持国家层面的健康大脑和儿童发育研究第二阶段的努力。在……里面 具体目标1，我们制定、实施和评估创新的招聘和留住高技能人才的战略 风险人群。这包括衡量可行性、吞吐量和人口统计特征 通过对每个站点150名孕妇的纵向调查，与不同的招聘方法相关联 (n=600个地点)，其中一半人在怀孕期间使用阿片类药物。预期的具体目标2 通过实施和评估多站点标准化研究，规划的第二阶段研究面临的挑战 方案包括胎盘、胎儿、新生儿和24个月大的大脑的多模式磁共振成像，生物样品收集， 以及对物质使用的评估，以及其他关键领域。不同方法的可行性、数据质量和有效性 评估方法将在20个母婴二元的纵向样本中进行评估(N=80个跨地点， 其中一半人在怀孕期间使用阿片类药物)，以及五名患有阿片类药物的24个月大儿童的横断面样本 产前阿片类药物暴露史(N=20个地点)。具体目标3评估数据采集、处理、 以及统计方面的考虑，以最大限度地提高数据质量、可用性和跨站点集成。为了实现这一目标，我们 观察实时运动监测对改善不同发育阶段MRI数据质量的效果 分期；测试新的MRI加速方案；协调胎儿、新生儿的数据和处理管道 和儿童核磁共振成为一个基于通用大脑的开源框架 成象 数据 结构 (出价) 和出价申请程序。该项目借鉴了调查人员招聘的基本经验 使用孕妇保留物质(母亲研究；ECHO)，与我们佛蒙特州的法律和 道德合作伙伴(如IRB、儿童保护服务等)，以及在大型多站点中的合作 神经发育研究(ABCD)。