4:4 Investigation of opioid exposure and neurodevelopment (iOPEN)

4:4 阿片类药物暴露和神经发育的调查 (iOPEN)

• 批准号: 9899554
• 负责人: Veerle Bergink
• 金额: $ 28.2万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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/9899554
• 关键词: 2 year old; Acceleration; Address; Affect; Age; Alcohol or Other Drugs use; Assessment tool; Attitude; Behavioral; Biological; Birth; Brain; Characteristics; Child; Childhood; Cognitive; Collection; Communities; Complex; Data; Data Collection; Data Quality; Data Set; Development; Disadvantaged; Dropout; Drops; Early Intervention; Electroencephalography; Elements; Emotional; Enrollment; Environmental Risk Factor; Ethnic Origin; Evaluation; Exposure to; Family; Fathers; Fetal Development; Fetus; Foundations; Goals; Health Sciences; Human; Image; Image Analysis; Infant; Infant Health; Institutes; Investigation; Knowledge; Lead; Learning; 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; Motion; Movement; Neonatal; Neonatal Abstinence Syndrome; New York; New York City; Opiate Addiction; Opioid; Opioid user; Oregon; Outcome; Participant; Patients; Personal Satisfaction; Persons; Phase; Population; Population Study; Positioning Attribute; Pregnancy; Pregnant Women; Probability; Prospective cohort study; Protocols documentation; Psychosocial Assessment and Care; Race; Recording of previous events; Research; Research Design; Research Personnel; Resources; Risk Factors; Role; Savings; Site; Socioeconomic Status; Standardization; Structure; Testing; Third Pregnancy Trimester; Time; Toddler; Ultrasonography; United States National Institutes of Health; Universities; Validation; Variant; Vermont; Work; biobehavior; critical period; data acquisition; data collection methodology; data sharing; demographics; design; early childhood; efficacy testing; experience; fetal; fetal drug exposure; fetal opioid exposure; flexibility; health assessment; high risk population; improved; incentive strategies; innovation; lifestyle factors; multidisciplinary; multimodality; neonatal magnetic resonance imaging; neonate; neurodevelopment; neuroimaging; novel; opioid exposure; opioid use; opioid use in pregnancy; phase 2 study; postnatal; preference; pregnant; prenatal; prospective; protective factors; recruit; research study; resilience; response; retention rate; social; success; tool; usability; young mother

PROJECT SUMMARY While the rate of neonatal abstinence syndrome has reached a staggering 6.5 per 1,000 births nationwide, the short- and long-term effects of opioid exposure are far from clear. We lack fundamental knowledge of neurotypical neonatal development and struggle to disentangle the effect of opioid exposure from other protective and risk factors impacting infant health. The fetal stage of brain development is a critical period when foundational aspects of brain structure and function are being established. In addition, postnatal brain development and specialization are shaped by environmental experiences thus allowing maturation to be influenced by lifestyle factors associated with opioid use. This Phase I project will plan for a large scale, multi- site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally through childhood. New York University is one of four linked applications collaborating with investigators at Oregon Health and Sciences University, University of Pittsburgh Medical Center and University of Vermont. Together, we will address key challenges that are critical to the success of the planned Phase II study. Aim 1 will develop, implement and evaluate innovative recruitment and retention strategies for high-risk populations. We will measure 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. Aim 2 will implement a multi- site, standardized, longitudinal research protocol by enrolling 20 pregnant women per site (n=80 across sites), half of whom use opioids during pregnancy. This prospective longitudinal study will collect fetal and neonatal multi-modal MRI, biospecimens, and maternal psychosocial and health assessments. Aim 3 will evaluate innovative MRI acquisition and processing strategies and statistical considerations intended to address key Phase II goals, including optimal measurement strategies and cross-site harmonization. Specifically, we will (a) evaluate strategies for cross-scanner and cross-time image harmonization; (b) test real-time evaluation of MRI data quality/motion during acquisition; (c) test the efficacy of accelerated image acquisition sequences; and (d) build fetal and neonatal MRI processing pipelines. Our New York investigative team contributes extensive experience leading studies in patients with opioid addiction, fetuses exposed to opioids, and longitudinal cohort studies in pregnant patients, young children, and difficult to reach populations. We have directed multiple consortia, performed large-scale population studies, and conducted multimodal MRI, EEG, and ultrasound studies in fetuses, neonates, and children. Our prior expertise in longitudinal modelling of infant MRI data and MRI methodology development suits us well to lead Aim 3's image harmonization and fetal/neonatal processing pipeline development. Additionally, the New York City population brings much-needed diversity across race, ethnicity, nativity, and socioeconomic status to the linked collaborative applications.

项目摘要 虽然新生儿禁欲综合症的发病率在全国范围内达到了惊人的千分之6.5， 接触类阿片的短期和长期影响远不清楚。我们缺乏基本的知识 神经典型的新生儿发育，并努力解开阿片类药物暴露的影响，从其他 影响婴儿健康的保护和风险因素。胎儿阶段是大脑发育的关键时期 当大脑结构和功能的基础方面正在建立时。此外，产后大脑 发展和专业化是由环境经验塑造的，因此允许成熟 与阿片类药物使用相关的生活方式因素的影响。该项目一期将规划一个大规模，多- 现场研究，前瞻性地检查人类大脑、认知、行为、社会和情感 从出生前到童年的发展。纽约大学是四个链接应用程序之一 与俄勒冈州健康与科学大学、匹兹堡大学医学院的研究人员合作， 中心和佛蒙特大学。我们将共同应对对联合国成功至关重要的关键挑战， 计划的第二阶段研究。目标1将制定、实施和评估创新的招聘和留用办法 针对高危人群的战略。我们将衡量可行性，吞吐量和人口统计 通过对150名孕妇的纵向调查，分析了不同招募方法的相关特征 每个研究中心的妇女人数（各研究中心n=600），其中一半在怀孕期间使用阿片类药物。目标2将实施一个多- 研究中心、标准化、纵向研究方案，每个研究中心招募20名孕妇（各研究中心n=80）， 其中一半在怀孕期间使用阿片类药物。这项前瞻性纵向研究将收集胎儿和新生儿 多模式MRI、生物样本以及孕产妇心理社会和健康评估。目标3将评估 创新的MRI采集和处理策略以及旨在解决关键问题的统计考虑因素， 第二阶段目标，包括最佳衡量战略和跨地点协调。具体而言，我们将（a） 评估跨扫描仪和跨时间图像协调的策略;（B）测试MRI的实时评估 采集期间的数据质量/运动;（c）测试加速图像采集序列的功效;以及（d） 建立胎儿和新生儿MRI处理管道。我们的纽约调查小组提供了大量 在阿片类药物成瘾患者、暴露于阿片类药物的胎儿和纵向队列中开展的领先研究经验 在妊娠患者、幼儿和难以接触的人群中进行的研究。我们已经指导了多个 财团，进行大规模的人口研究，并进行多模式MRI，EEG和超声 胎儿、新生儿和儿童的研究。我们先前在婴儿MRI数据纵向建模方面的专业知识， MRI方法学的发展非常适合我们领导Aim 3的图像协调和胎儿/新生儿 加工管道的发展。此外，纽约市的人口带来了急需的多样性 跨越种族、民族、出生地和社会经济地位，以链接协作应用程序。