Study of Pregnancy And Neonatal Health (SPAN)

妊娠和新生儿健康研究 (SPAN)

• 批准号: 10684582
• 负责人: Edwina Yeung
• 金额: $ 85.21万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684582
• 关键词: Acceleration; Affect; African American population; Age; Aging; Alabama; Anthropometry; Biological; Birth; COVID-19 pandemic; Clinical; Clinical Trials; Collaborations; Data; Data Collection; Data Coordinating Center; Databases; Development; Disease; Epigenetic Process; Fetal Growth; Gene Expression; Genetic; Gestational Diabetes; Goals; Health; Institutional Review Boards; Lead; Learning; Link; Louisiana; Manuals; Measures; Monitor; National Institute of Child Health and Human Development; Neonatal; North Carolina; Pathway interactions; Pennsylvania; Perinatal mortality demographics; Population; Pregnancy; Pregnancy Outcome; Pregnant Women; Procedures; Protocols documentation; Research; SARS-CoV-2 infection; Safety; Sampling; Seminal fluid; System; Time; Training; Utah; Variant; Virginia; adverse pregnancy outcome; cardiovascular risk factor; clinical research site; cohort; father role; fetal; genetic approach; genome wide association study; genomic locus; insight; male; neonatal health; neonatal morbidity; pregnancy health; recruit; secondary analysis

Recruitment is anticipated at eight clinical sites located in North Carolina, Utah, Alabama, Virginia, Pennsylvania, and Louisiana. We anticipate about 11,525 pregnant women with about 3825 of their male partners to be recruited. Data will be captured using the NICHD Clinical Trials Data Base and in collaboration with a data coordinating center (DCC). Protocol and data collection forms are finalized and IRB review is underway. A detailed manual of procedures for the study and a data safety monitoring plan for the trial component are being finalized. Study forms are being programmed into the Clinical Trials Data Base and a learning management system is being developed by the DCC to manage staff training. The COVID-19 pandemic has caused some delays.

预计将在北卡罗莱纳州、犹他州、阿拉巴马州、弗吉尼亚州、宾夕法尼亚州和路易斯安那州的八个临床地点进行招聘。我们预计将招募约11525名孕妇和约3825名男性伴侣。数据将使用NICHD临床试验数据库并与数据协调中心（DCC）合作获取。方案和数据收集表已定稿，内部审查委员会正在进行审查。目前正在最后确定研究程序的详细手册和试验部分的数据安全监测计划。研究表格正在编入临床试验数据库，临床试验中心正在开发一个学习管理系统来管理工作人员培训。COVID-19大流行造成了一些延误。