1/5, HEAL Consortium: Establishing Innovative Approaches for the HEALthy Brain and Child Development Study

1/5，HEAL 联盟：建立健康大脑和儿童发展研究的创新方法

基本信息

批准号：
9900350
负责人：
JOHN Horace GILMORE
金额：
$ 26.24万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
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/9900350
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

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

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项目摘要

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幅度大大增加，因此增加了5倍以上自2000年以来，已经报道了新生儿禁欲综合征（NAS）的发生率。初步研究证明产前阿片类药物暴露与整个神经发育受损的风险增加有关认知，运动和行为领域。因此，严格表征产前影响的研究迫切需要在早期大脑发育中暴露于卵子。在我们的申请中，五个机构（杜克伊利诺伊大学辛辛那提儿童医院阿肯色大学儿童研究所大学拥有完整的专业知识，成立了一个财团来制定为第二阶段健康的大脑和儿童发展做准备的策略研究是一项计划的大规模多站点研究，以检查产前药物的长期影响长期童年成果的接触。利用我们的多学科团队的独特技能，我们将制定基本工具和策略（招聘/保留协议，评估电池和新颖 II期研究的工具（AIM 1）。我们将进行试点研究（胎儿和产后成像，晚期成像协调和质量控制，评估管理，生物采样）以评估工具对于II期研究（AIM 2）。最后，我们将分析可用数据（AIM 3），包括成像，行为，研究的认知和孕产妇数据着重于早期大脑发育，向指导II期研究设计。拟议的目标完成后，我们的财团将处于理想状态进行未来II期研究的位置。