The “DUC” trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation

Abstract

Purpose To determine the feasibility of a randomized controlled trial of delayed umbilical cord clamping in preterm infants. Methods Following informed consent, women between 24 to 32 weeks gestation experiencing imminent preterm birth were randomly assigned to either an immediate cord clamping (ICC) or delayed cord clamping (DCC) group. Umbilical cord clamping directions were 0–15 s for the ICC group and 30–45 s for the DCC group. Information regarding recruitment rate and trial compliance was collected. Neonatal outcomes of intraventricular hemorrhage (IVH), sepsis, anemia, and hyperbilirubinemia were also compared between the two groups. This trial was registered at https://clinicaltrials.gov/. (ClinicalTrials.gov Identifier: NCT00562536). Results Thirty-eight women were recruited in total, 19 each to the ICC and DCC groups respectively. The study recruitment rate was 33% and study compliance rate was 97%. The average time for cord clamping was 5.4 s in the ICC group and 39.7 s in the DCC group (p < .05). The incidence of IVH and sepsis was the same in both groups (16 and 11% respectively). Thirty-seven percent of the ICC group and 21% of the DCC group required a blood transfusion. Hyperbilirubinemia requiring phototherapy occurred in 37% of the ICC group and 26% of the DCC group. Conclusion This study demonstrates that a trial of a short delay in umbilical cord clamping (30–45 s) is feasible for women and physicians. Larger scale studies of long term outcomes are warranted.