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: 10271386
• 负责人: DANIEL MOLINA
• 金额: $ 25.58万
• 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/10271386
• 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; Newsletter; Online Systems; Perinatal mortality demographics; 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; response; social media; web site

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of Intramural 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 response adaptive randomization to determine the optimal timing of delivery for gestational diabetes complicated pregnancies between 37-39 weeks relative to neonatal morbidity and perinatal 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/).

尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)， 内部人口健康研究部(DIPHR)需要数据协调服务 妊娠与新生儿健康研究(SPAN)。SPAN是一个潜在的怀孕队列 招募怀孕早期的妇女，并在整个怀孕期间保留她们，使她们有可能 长期随访。这项研究有三个具体目标： 1)父亲对DOHaD的贡献(DAD目标)：确定父亲的心血管风险和精液 与胎儿生长、新生儿体格测量和胎盘相关的表观遗传因素 特点； 2)胎儿生长和胎盘老化的遗传学(gGAP目标)：确定潜在的遗传机制 胎儿生长、新生儿人体测量和胎盘表观遗传老化； 3)妊娠期糖尿病的分娩时间(时间目标)：进行临床试验 应用反应自适应随机化方法确定妊娠最佳分娩时机 糖尿病合并妊娠37-39周与新生儿发病率和围产儿的关系 死亡率。 这一倡议是为了数据协调服务，最终将提供 将从SPAN研究中收集的数据的数据集和统计分析。本研究 涉及负责招聘和注册的多个学习地点。数据 协调中心(DCC)(本任务单)负责组织数据安全和 试验组件的监控板(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