Healthy Brain and Child Development National Consortium Data Coordinating Center

项目总结 具有里程碑意义的健康大脑和儿童发展(HBCD)研究将提供具有代表性的参考数据 为科学界提供资源，使人们能够对神经发育及其影响进行前所未有的研究 环境、遗传和生物因素对大脑和行为健康以及发育轨迹的影响 从婴儿期到儿童期。通过这项研究，HBCD财团将招募和保留一名 来自25个U01站点的7,500名孕妇的社会人口学多样性队列(以及另外5个分包合同 总共30个数据收集站点)，并跟踪这些家庭及其子女通过 生命的第一个十年。儿童将接受包括神经成像在内的各种方式的严格数据收集， 神经生理学、行为和认知评估，以及通过研究方案收集生物样本 由领域领先的专家开发。健康大脑和儿童发展数据协调中心(HDCC； U24 DA055330)将领导、管理和监督数据收集、质量控制、 管理、处理、管理、共享和分析，以促进和支持HBCD的活动 并确保其成功。这一行政补充是必要的，以满足重要的 在原始HDCC提交文件中未编入预算的费用，以及成功建立这些费用所需的费用 程序。如详细所述，这些成本与原始范围之外的多个因素直接相关 提案，包括：1)U01和分包工地的数量比最初预算的多 HBCD财团的最终配置；2)由于通货膨胀，所需计算机硬件的成本增加- 与供应链相关的成本自2021年3月首次提交以来有所增加；3)更大的数据存储 基础设施需求，以适应根据最终数据收集的更多PII数据 联盟定义的研究方案；4)关键研究要素的不同水平的经验和专业知识(例如， 在不使用镇静药物的情况下对婴儿和蹒跚学步的儿童进行MRI扫描 站点；以及5)被联盟确定为对成功的MRI至关重要的项目的不同现有资源 通过HBCD联盟站点收集数据(例如，降噪耳机)。关键是，所请求的 支持仅限于财团第一年的活动所需的项目，以满足研究时间表和 促进在所有U01和分包地点成功、协调地启动多式联运议定书， 同时确保人类发展协调委员会支持的数据收集和管理程序的准确性。 这一领域领先调查的结果将是无与伦比的规模的最先进的纵向数据集 它提供了对影响儿童健康的生物和环境因素的深刻理解， 以及行为发展，并塑造未来几十年的研究、临床护理和公共政策。

PROJECT SUMMARY The landmark Healthy Brain and Child Development (HBCD) study will provide a representative reference data resource to the scientific community enabling unprecedented investigation of neurodevelopment and the impact of environmental, genetic, and biological factors on brain and behavioral health and developmental trajectories from infancy through childhood. Through this study, the HBCD Consortium will recruit and retain a sociodemographically diverse cohort of 7,500 pregnant women from 25 U01 sites (and five additional subcontract sites for 30 total data collection sites) across the U.S. and follow these families and their children through the first decade of life. Children will undergo rigorous data collection across modalities including neuroimaging, neurophysiology, behavioral and cognitive assessments, and collection of biospecimens via a study protocol developed by field-leading experts. The Healthy Brain and Child Development Data Coordinating Center (HDCC; U24 DA055330) will provide the leadership, management, and oversight of data collection, quality control, curation, processing, management, sharing, and analytics to facilitate and support the activities of the HBCD Consortium and ensure its success. This administrative supplement is necessary to accommodate significant costs unbudgeted in the original HDCC submission and required for the successful establishment of these procedures. As detailed, these costs are directly related to multiple factors outside the purview of the original proposal, including: 1) a larger number of U01 and subcontract sites than originally budgeted based upon the final configuration of the HBCD Consortium; 2) greater costs for required computer hardware due to inflation- and supply chain-related cost increases since the original submission in March 2021; 3) greater data storage infrastructure requirements to accommodate collection of increased amounts of PII data based upon the final Consortium-defined study protocol; 4) varying levels of experience and expertise with key study elements (e.g., performing MRI scans in infants and toddlers without the use of sedating medications) across HBCD Consortium sites; and 5) varying extant resources for items determined by the Consortium to be critical for successful MRI data collection (e.g., noise attenuating headphones) across HBCD Consortium sites. Critically, the requested support is only for items required in Year 1 of the Consortium’s activities in order to satisfy study timelines and facilitate the successful, coordinated launch of the multimodal protocol across all U01 and subcontract sites, while concomitantly ensuring the fidelity of data collection and management procedures supported by the HDCC. The result of this field leading investigation will be a state-of-the-art, longitudinal data set of unparalleled scale which provides deep understanding of the biological and environmental factors that affect a child’s health, brain, and behavioral development and shapes research, clinical care, and public policy for decades to come.