3/3; Promoting resilience in children:Protocol Development for a Birth Cohort Study to Access Factors Impacting Neurodevelopment

促进儿童的复原力：出生队列研究方案的制定 评估影响神经发育的因素 摘要 生命的前十年伴随着大脑和认知能力的快速变化。一 许多复杂的相互作用的因素，包括遗传学，早期生活暴露于物质，家庭和社会 互动，家庭和社区环境可以影响大脑和认知的轨迹 发展对这些影响和相互作用的充分研究受到几个因素的限制， 包括与招募和保留服用产前药物的孕妇相关的挑战 使用;与使用药物的孕妇研究相关的法律的、伦理和监管问题， 儿童;以及在没有镇静剂的情况下对婴儿和幼儿进行神经成像的困难。这些 三个相互联系和协同作用的项目旨在通过开展有效的研究来应对这些挑战 协议，为未来成功的大规模，国家健康的大脑和认知 六溴环十二烷出生队列研究，该研究将跟踪十年的发展轨迹。项目 1.将制定方案，招募和保留各种孕妇和产后妇女样本 对产前使用阿片类药物的母亲进行了过度抽样。项目2将确定道德、法律的和监管的 在这一弱势群体中开展调查的挑战，并随后确定有效的解决办法， 能够招募和研究这些参与者。项目3将制定和评估获取 通过磁共振成像和功能近距离成像进行高质量、定量神经成像测量 红外光谱，以及评估有效的策略，测量认知性能的年轻人 儿童，包括接触阿片类药物的儿童。这些相互联系的项目对于解决主要的 计划的六溴环十二烷研究面临的挑战，并将利用高度协作的多学科团队; 领先的神经成像技术和杰出的机构资源。

PROMOTING RESILIENCE IN CHILDREN: PROTOCOL DEVELOPMENT FOR A BIRTH COHORT STUDY TO ASSESS FACTORS IMPACTING NEURODEVELOPMENT ABSTRACT The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. A multitude of complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect the trajectories of brain and cognitive development. Adequate investigations of these effects and interactions have been limited by several factors, including challenges associated with the recruitment and retention of pregnant women with prenatal substance use; the legal, ethical and regulatory issues associated with studies of substance-using pregnant women and children; and the difficulties of performing neuroimaging in infants and young children without sedation. These three linked and synergistic projects aim to address these challenges by developing effective research protocols to lay a foundation for a successful future large-scale, national HEALthy Brain and Cognitive Development (HBCD) birth cohort study, which will follow the developmental trajectories for a decade. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal and regulatory challenges for investigations in this vulnerable population, and subsequently define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy, as well as assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. These linked projects are essential to address the major challenges with the planned HBCD study and will leverage a highly collaborative, multidisciplinary team; leading-edge neuroimaging techniques; and outstanding institutional resources.