DATA COORDINATING CENTER FOR THE STUDY OF PREGNANCY AND NEONATAL HEALTH (SPAN)

妊娠和新生儿健康研究数据协调中心 (SPAN)

• 批准号: 10021081
• 负责人: DANIEL MOLINA
• 金额: $ 143.85万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-17 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10021081
• 关键词: Aging; Anthropometry; Characteristics; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Database; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Database Management Systems; Development; Documentation; Enrollment; Epigenetic Process; Facebook; Fetal Growth; Genetic; Gestational Diabetes; Health; Longterm Follow-up; Monitor; National Institute of Child Health and Human Development; Neonatal; Neonatal Mortality; Newsletter; Online Systems; Pregnancy; Preparation; Randomized; Research; Scheme; Seminal fluid; Services; Site; Statistical Data Interpretation; System; Training Activity; Visit; Woman; cardiovascular risk factor; clinical research site; cohort; computerized data processing; data management; data quality/integrity; early pregnancy; neonatal morbidity; population health; prospective; recruit; social media; trial design; web site

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of lntramural Population Health Research (DIPHR) requires data coordinating services for the Study of Pregnancy And Neonatal health (SPAN). SPAN is a prospective pregnancy cohort recruiting women in early pregnancy and retaining them throughout pregnancy with potential for long-term follow-up. The Study has three specific aims - 1) Paternal Contribution to DOHaD (DAD aim): Determine paternal cardiovascular risk and semen epigenetic factors associated with fetal growth, neonatal anthropometry, and placental characteristics; 2) Genetics of fetal Growth And Placental aging (gGAP aim): Identify genetic mechanisms underlying fetal growth, neonatal anthropometry, and placental epigenetic aging; and 3) Timing of delivery for GDM (Gestational Diabetes Mellitus) (TIME aim): Perform a clinical trial using an adaptive trial design to determine the optimal timing of delivery for gestational diabetes complicated pregnancies between 38-39 weeks relative to neonatal morbidity and mortality. This initiative is for the data coordinating services that will ultimately provide the final dataset and statistical analyses of the data that will be collected from the SPAN Study. This study involves multiple study sites that are responsible for recruitment and enrollment. The data coordinating center (DCC) (this task order) is responsible for organizing a data safety and monitoring board (DSMB) for the trial component. The web-based data collection system will be established by the NICHD's Clinical Trial Database (CTDB, https://ctdb.nichd.nih.gov/ctdb/). SCOPE To provide data coordinating services for "the Study of Pregnancy And Neonatal Health." The purpose of this task order is to procure the services of a DCC for preparation, training activities, enrollment and data collection and data analysis of the SPAN study. The DCC shall aid in implementing a web-based data management system from the NICHD CTDB. Major responsibilities include coordination and management of data collection, assuring data quality and integrity, producing thorough data documentation, cleaning and verifying the data, processing, tracking (study visits, data entry and biospecimens), supporting administrative and regulatory requirements and statistical analyses. In addition, the DCC is responsible for reviewing the study website and working closely with the clinical sites to monitor and oversee the study. The DCC is also responsible for providing a randomization scheme and organizing a DSMB for the clinical trial component of the study and providing a plan for the interim analysis of trial findings. Moreover, the DCC will have the responsibility of providing graphic expertise for newsletter development, study website, and social media (e.g. Facebook posts), as needed.

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 校内人口健康研究部 (DIPHR) 需要为妊娠和新生儿健康研究 (SPAN) 提供数据协调服务。 SPAN 是一个前瞻性妊娠队列，招募怀孕早期的女性，并在整个怀孕期间保留她们，并有可能进行长期随访。该研究有三个具体目标 - 1) 父亲对 DOHaD 的贡献（DAD 目标）：确定父亲心血管风险以及与胎儿生长、新生儿人体测量和胎盘特征相关的精液表观遗传因素； 2）胎儿生长和胎盘衰老的遗传学（gGAP目标）：识别胎儿生长、新生儿人体测量和胎盘表观遗传衰老的遗传机制；和 3) GDM（妊娠糖尿病）的分娩时机（TIME 目标）：使用适应性试验设计进行临床试验，以确定妊娠期糖尿病并发妊娠 38-39 周相对于新生儿发病率和死亡率的最佳分娩时机。 该举措旨在提供数据协调服务，最终提供最终数据集以及对从 SPAN 研究中收集的数据进行统计分析。这项研究涉及多个负责招募和入组的研究中心。数据协调中心（DCC）（本任务订单）负责为试验组件组织数据安全和监控委员会（DSMB）。基于网络的数据收集系统将由 NICHD 的临床试验数据库（CTDB，https://ctdb.nichd.nih.gov/ctdb/）建立。 范围 为“妊娠与新生儿健康研究”提供数据协调服务。该任务订单的目的是采购 DCC 的服务，以进行 SPAN 研究的准备、培训活动、注册以及数据收集和数据分析。 DCC 应协助实施 NICHD CTDB 的基于网络的数据管理系统。主要职责包括协调和管理数据收集、确保数据质量和完整性、生成完整的数据文档、清理和验证数据、 处理、跟踪（研究访问、数据输入和生物样本）、支持行政和监管要求以及统计分析。此外，DCC 还负责审查研究网站并与临床中心密切合作以监测和监督研究。 DCC 还负责提供随机方案并为研究的临床试验部分组织 DSMB，并为试验结果的中期分析提供计划。此外，DCC 将负责根据需要为时事通讯开发、研究网站和社交媒体（例如 Facebook 帖子）提供图形专业知识。