E.W. "Al" Thrasher
Status: Funded - Open
Summary
BACKGROUND: The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental impairment of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age. GAP: There is limited evidence of long term neurodevelopmental benefit with umbilical cord milking compared to delayed cord clamping in premature infants. HYPOTHESIS: We hypothesize that infants receiving umbilical cord milking at birth will have similar or improved neurodevelopmental outcomes at 2 years corrected age compared to infants that receive delayed cord clamping at birth. METHODS: This multicenter international trial will enroll approximately 1,000 children randomized at birth to delayed cord clamping of 60 seconds or more compared to milking the intact cord 4 times prior to clamping. RESULTS: Pending IMPACT: If umbilical cord milking is found to have similar or improved neurodevelopmental outcomes at 2 years corrected age, it will change cord management for preterm infants worldwide. Website Link: www.sharp.com/nri; www.premod2.org