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

NIH RePORTER · NIH · N01 · $255,763 · view on reporter.nih.gov ↗

Abstract

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/).

Key facts

NIH application ID
10271386
Project number
275201800013I-P00002-759401900125-1
Recipient
TECHNICAL RESOURCES INTERNATIONAL, INC.
Principal Investigator
DANIEL MOLINA
Activity code
N01
Funding institute
NIH
Fiscal year
2020
Award amount
$255,763
Award type
Project period
2019-09-17 → 2024-07-31