Healthy Brain and Child Development National Consortium Data Coordinating Center

健康大脑和儿童发展国家联盟数据协调中心

• 批准号: 10577683
• 负责人: ANDERS M DALE
• 金额: $ 72.2万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10577683
• 关键词: Administrative Supplement; Affect; Attenuated; Behavior assessment; Behavioral; Biological Factors; Brain; Budgets; Child; Child Development; Child Health; Childhood; Collection; Communities; Computer Hardware; Data; Data Collection; Data Coordinating Center; Data Storage and Retrieval; Development; Elements; Ensure; Environmental Impact; Environmental Risk Factor; Family; Genetic; Infant; Infrastructure; Investigation; Leadership; Life; MRI Scans; Magnetic Resonance Imaging; Modality; Mothers; Noise; Pharmaceutical Preparations; Pregnant Women; Price; Procedures; Protocols documentation; Public Policy; Quality Control; Research; Resources; Secondary to; Shapes; Site; TimeLine; Toddler; base; behavioral health; brain health; clinical care; cognitive testing; cohort; cost; data collection site; data management; data resource; experience; infancy; longitudinal dataset; multimodality; neurodevelopment; neuroimaging; neurophysiology; recruit; sociodemographics; success

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.

项目概要 具有里程碑意义的健康大脑与儿童发育（HBCD）研究将提供具有代表性的参考数据 为科学界提供资源，以便对神经发育及其影响进行前所未有的调查 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 通过这项研究，六溴环十二烷联盟将招募并留住从婴儿期到儿童期的儿童。 来自 25 个 U01 站点（以及另外 5 个分包商）的 7,500 名孕妇组成的社会人口学多样化队列 网站（总共 30 个数据收集网站），并通过以下方式跟踪这些家庭及其孩子： 儿童在生命的第一个十年将接受严格的数据收集，包括神经影像学、 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。健康大脑和儿童发育数据协调中心（HDCC； U24 DA055330）将提供数据收集、质量控制、 策划、处理、管理、共享和分析，以促进和支持 HBCD 的活动 财团并确保其成功，这一行政补充对于容纳重大资金是必要的。 原始 HDCC 提交文件中未列入预算的费用，以及成功建立这些机构所需的费用 详细而言，这些成本与原始范围之外的多种因素直接相关。 提案，包括： 1) U01 和分包站点的数量比最初根据 HBCD 联盟的最终配置；2) 由于通货膨胀，所需计算机硬件的成本增加 - 自 2021 年 3 月首次提交以来，供应链相关成本增加 3) 更大的数据存储； 基础设施要求，以适应根据最终结果收集更多数量的 PII 数据 联盟定义的研究方案；4) 不同水平的经验和专业知识以及关键研究要素（例如， HBCD 联盟在不使用镇静药物的情况下对婴儿和幼儿进行 MRI 扫描 5) 联盟确定的对成功 MRI 至关重要的项目的不同现有资源 跨 HBCD 联盟站点的数据收集（例如降噪耳机）至关重要。 支持仅适用于联盟活动第一年所需的项目，以满足研究时间表和 促进在所有 U01 和分包站点成功、协调地启动多式联运协议， 同时确保 HDCC 支持的数据收集和管理程序的保真度。 这一领域领先的调查结果将是一个规模空前的最先进的纵向数据集 它提供了对影响儿童健康、大脑、 和行为发展，并塑造未来几十年的研究、临床护理和公共政策。