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UMBILICAL CORD MILKING IN NON-VIGOROUS INFANTS: A PRAGMATIC CLUSTER-RANDOMIZED CROSSOVER TRIAL
- Anup Katheria (United States of America)
Abstract
Background and Aims
In non-vigorous term/late-preterm infants, early cord clamping (ECC) remains the usual approach. Umbilical cord milking (UCM) may be an alternative. We tested whether UCM, compared to ECC, reduces NICU admission risk based on predefined criteria.
Methods
A pragmatic cluster-randomized crossover trial of infants born at ≥35 weeks gestation from 10 Neonatal Intensive Care Units (NICUs) in 3 countries. Non-vigorous newborns at birth were assigned to UCM or ECC according to their hospital randomization assignment. Deferred consent was obtained to implement the intervention. Baseline characteristics and outcomes were collected following delayed informed consent.
Results
Among 16,234 screened newborns, 1780 were eligible, 1730 had primary outcome data for analysis (97% of eligible; 872 UCM, 858 ECC) via informed or waived consent. NICU admissions did not differ significantly between UCM (23%) and ECC (28%) groups (OR 0.69, 95% CI 0.41-1.14). UCM was associated with lower odds of an abnormal 1-minute Apgar score (Apgar ≤3 30% vs 34%, OR 0.72, 95%CI 0.56-0.92; Apgar 4-6 33% vs 36% OR 0.74, 95%CI 0.58-0.95), and decreased need for therapeutic hypothermia (3% vs 4%, OR 0.57, 95% CI 0.33-0.99). No safety (death, intraventricular hemorrhage, or exchange transfusion) difference was observed (0.1% UCM, 0.7% ECC).
Conclusions
UCM did not reduce NICU admission compared with ECC in non-vigorous newborns. UCM may improve 1-minute Apgar scores and reduce respiratory support and the need for therapeutic hypothermia. Given its safety and potential efficacy, UCM may be considered for non-vigorous term/late-preterm newborns.