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).

项目摘要 新生儿禁欲综合症的发病率在全国范围内达到了惊人的每1 000名新生儿6.5例， 根据疾病预防控制中心的数据，佛蒙特州每1,000人中有48.6人患有阿片类药物使用障碍， 在美国交货。这种情况迫切需要确定子宫内暴露于阿片类药物， 相关的风险因素会影响大脑的发育。对这一主题进行严格的科学调查需要 解决缺乏神经发育的基础知识。此外，由于产后 大脑发育受环境经验的影响，重要的是要区分环境经验对大脑发育的影响。 与阿片类药物使用相关的生活方式因素的产前阿片类药物暴露。该提案汇集了一个 拥有专业知识、经验和机构支持的多学科团队，以应对这些挑战， 佛蒙特州是一个农村州，受到阿片类药物流行病的严重打击。通过与其他三个网站的链接， 俄勒冈州健康与科学大学、纽约大学和匹兹堡大学医学中心， 该项目的影响力大大增强。第一阶段应用中的活动将提供关键的 信息，以支持国家一级的努力，第二阶段的健康大脑和儿童发展研究。在 具体目标1，我们制定，实施和评估创新的招聘和保留战略， 风险人群。这包括测量可行性、吞吐量和人口统计特征 通过对每个研究中心150名孕妇的纵向调查， （各研究中心n=600），其中一半在妊娠期间使用阿片类药物。具体目标2预期解决 通过实施和评估一项多中心、标准化的研究， 方案包括胎盘、胎儿、新生儿和24月龄脑的多模式MRI，生物标本采集， 和物质使用评估以及其他关键领域。可行性，数据质量和不同的疗效 评估方法将在20对母婴的纵向样本中进行评估（N=80个研究中心， 其中一半在怀孕期间使用阿片类药物），以及5名24个月大的儿童的横断面样本， 产前阿片类药物暴露史（各研究中心N=20）。具体目标3评估数据采集，处理， 和统计考虑因素，以最大限度地提高数据质量、可用性和跨站点集成。为此，我们 检查实时运动监测在不同发育阶段改善MRI数据质量的有效性 阶段;测试新的MRI加速协议;并协调胎儿，新生儿 和儿童核磁共振成像到一个基于通用大脑的开源框架中 成像 数据 结构 （投标） 和BIDS应用程序例程。这个项目借鉴了调查人员的基本经验， 和保留物质使用孕妇（母亲研究; ECHO），与我们的佛蒙特州法律的和 伦理合作伙伴（即IRB、儿童保护服务等），并在大型多站点合作， 神经发育研究（ABCD）。