3/5 HEAL Consortium: Establishing Innovative Approaches for the HEALthy Brain and Child Development Study

3/5 HEAL 联盟：建立健康大脑和儿童发展研究的创新方法

• 批准号: 10007991
• 负责人: ASHLEY ACHESON
• 金额: $ 25.82万
• 依托单位: ARKANSAS CHILDREN'S HOSPITAL RES INST
• 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/10007991
• 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

ABSTRACT 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.

抽象的 孕妇中阿片类药物的使用显着增加，因此增加了 5 倍以上 自 2000 年以来就有报道称，新生儿戒断综合症 (NAS) 的发病率较高。初步研究 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，需要进行严格表征产前影响的研究 阿片类药物暴露对早期大脑发育至关重要。在我们的申请中，五个机构（杜克大学 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 厄巴纳-香槟分校和北卡罗来纳大学教堂山分校）具有互补的专业知识， 成立了一个联盟来制定战略，为第二阶段的健康大脑和儿童发展做准备 研究，一项计划进行的大规模多地点研究，旨在检验产前药物的长期影响 暴露于长期的童年结局。利用我们多学科团队的独特技能，我们将 制定基本工具和战略（招聘/保留协议、评估组合和新颖的 工具）用于第二阶段研究（目标 1）。我们将进行试点研究（胎儿和产后成像、先进的 成像协调和质量控制、评估管理、生物采样）来评估仪器 用于第二阶段研究（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亲数据，为 指导II期研究设计。完成拟议目标后，我们的联盟将处于理想状态 以便开展未来的二期研究。