4/5 HEAL Consortium: Establishing Innovative Approaches for the HEALthy Brain and Child Development Study

4/5 HEAL 联盟：建立健康大脑和儿童发展研究的创新方法

• 批准号: 9900280
• 负责人: STEPHANIE L MERHAR
• 金额: $ 26.83万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 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/9900280
• 关键词: Adopted; Affect; Age; Alcohol or Other Drugs use; Arkansas; Behavior assessment; Behavioral; Brain; Child; Child Development; Childhood; Cognitive; Collaborations; Collection; Complex; Data; Data Analyses; Development; Environmental Exposure; Equilibrium; Exposure to; Family; Family history of; Frequencies; Future; Grant; Growth; Home environment; Illinois; Image; Impairment; Incidence; Infant; Institution; Machine Learning; Magnetic Resonance Imaging; Meconium; Mothers; Motor; Neonatal Abstinence Syndrome; North Carolina; Opioid; Outcome; Parent-Child Relations; Participant; Pediatric Hospitals; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physiology; Pilot Projects; Play; Positioning Attribute; Pregnancy; Pregnant Women; Protocols documentation; Psychologist; Psychopathology; Quality Control; Readiness; Reporting; Research Design; Research Institute; Risk; Role; Saliva; Sampling; Site; Standardization; Structure; Substance Use Disorder; Third Pregnancy Trimester; Toddler; Training; Umbilical cord structure; United States National Institutes of Health; Universities; Work; base; childhood adversity; cognitive development; cognitive testing; design; drug exposure in utero; experience; fetal; fetal drug exposure; fetal opioid exposure; in utero; innovation; instrument; member; multidisciplinary; neurodevelopment; neuroimaging; novel; opioid epidemic; opioid exposure; opioid use; pediatrician; phase 2 designs; phase 2 study; postnatal; prenatal; real-time images; recruit; research study; sample collection; skills; tool; treatment program; wearable device

Opioid use among pregnant women is increasing significantly, and consequently, a more than 5-fold increase in the incidence of neonatal abstinence syndrome (NAS) has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment across cognitive, motor and behavioral domains. Therefore, studies to rigorously characterize the impacts of prenatal opioid exposure on early brain development are critically needed. In our application, five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana-Champaign and University of North Carolina at Chapel Hill) with complementary expertise, have formed a consortium to develop strategies to prepare for the Phase II HEALthy Brain and Child Development Study, a planned large scale multi-site research study to examine the long-term impact of prenatal drug exposure on long term childhood outcomes. Leveraging the unique skills of our multidisciplinary team, we will develop essential instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools) for the Phase II study (Aim 1). We will conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments for the Phase II study (Aim 2). Finally, we will analyze available data (Aim 3), including imaging, behavioral, cognitive and maternal data from studies focusing on early brain development, to provide critical information to guide the Phase II study design. Upon completion of the proposed aims, our consortium will be in an ideal position to conduct the future Phase II study.

孕妇中阿片类药物的使用正在显著增加，因此增加了5倍以上。 新生儿禁欲综合征(NAS)的发病率自2000年以来一直有报道。初步研究 表明产前阿片类药物暴露与神经发育受损的风险增加有关 认知、运动和行为领域。因此，严格描述产前影响的研究 阿片类药物对大脑早期发育的影响是非常必要的。在我们的应用程序中，有五个机构(杜克大学 阿肯色州儿童研究所，辛辛那提儿童医院，伊利诺伊大学 Urbana-Champaign和北卡罗来纳大学教堂山分校)拥有互补的专业知识， 成立了一个联合体，制定战略，为第二阶段健康的大脑和儿童发育做准备 这项研究是一项计划中的大规模多地点研究，旨在检查产前药物的长期影响 暴露于儿童的长期结果。利用我们多学科团队的独特技能，我们将 制定必要的工具和战略(招聘/留用方案、评估小组和新的 工具)用于第二阶段研究(目标1)。我们将进行初步研究(胎儿和出生后成像，高级 成像协调和质量控制、评估管理、生物采样)以评估仪器 第二阶段研究(目标2)。最后，我们将分析可用数据(目标3)，包括成像、行为、 来自专注于早期大脑发育的研究的认知和母体数据，为 指导第二阶段研究设计。在完成拟议的目标后，我们的财团将处于理想状态 进行未来第二阶段研究的职位。