This study was designed to determine whether umbilical cord milking (UCM) is at least as good as, or better than, delayed cord clamping (DCC) to reduce a composite of severe bleeding in the brain (intraventricular hemorrhage grade 3 or 4) or death in premature newborns. The investigators study short and long term outcomes of infants delivered between 23 and 32 weeks gestation that receive either UCM or DCC. Trial enrollment was stopped early for safety concerns, with unexpectedly high rates of severe IVH in extremely preterm infants. The study subsequently resumed, enrolling only older infants between 29-32 weeks gestation. The follow-up phase of the study is currently underway to evaluate child neurodevelopment at 2 years of age.
- 19 international sites
- 1201 infants randomized
- Non-inferiority RCT, stratified by gestational age
- NICHD funded, NCT: NCT03019367
- Website: https://premod2.org/
- Clinicaltrials.gov website: https://clinicaltrials.gov/search?term=NCT03019367