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.

项目概要 尽管全国新生儿戒断综合症的发病率已达到惊人的每1000名新生儿中有6.5人， 接触阿片类药物的短期和长期影响尚不清楚。我们缺乏基本知识 神经典型的新生儿发育，并努力将阿片类药物暴露与其他药物的影响区分开来 影响婴儿健康的保护性和危险因素。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，从而使成熟得以实现 受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、多用途的 前瞻性研究人类大脑、认知、行为、社交和情感的现场研究 发育从产前开始直至童年。纽约大学是四个链接申请之一 与俄勒冈健康与科学大学、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保留 针对高危人群的策略。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，与不同招募方式相关的特征 每个地点的女性（各地点 n=600），其中一半在怀孕期间使用阿片类药物。目标 2 将实施多项 站点，标准化纵向研究方案，每个站点招募 20 名孕妇（各站点 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 多模态 MRI、生物样本以及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统计考虑旨在解决关键问题 第二阶段目标，包括最佳测量策略和跨站点协调。具体来说，我们将 (a) 评估跨扫描仪和跨时间图像协调策略； (b) 测试MRI实时评估 采集过程中的数据质量/运动； (c) 测试加速图像采集序列的功效；和（四） 建立胎儿和新生儿 MRI 处理管道。我们的纽约调查团队做出了广泛的贡献 体验对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的领先研究 针对孕妇、幼儿和难以接触人群的研究。我们曾指导过多个 联盟，进行大规模人群研究，并进行多模态 MRI、EEG 和超声检查 对胎儿、新生儿和儿童的研究。我们之前在婴儿 MRI 数据纵向建模方面的专业知识和 MRI 方法的开发非常适合我们领导 Aim 3 的图像协调和胎儿/新生儿 加工管道开发。此外，纽约市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来链接协作应用程序。