Effect of intact cord resuscitation versus conventional cord clamping on clinical outcomes in very preterm neonates: a randomized controlled trial from Eastern India.

Abstract

Early umbilical cord clamping during delivery-room resuscitation may interrupt placental transfusion during cardiopulmonary transition, increasing neonatal morbidity and mortality. This study aimed to evaluate whether intact cord resuscitation (ICR) improves delivery-room stabilization and clinical outcomes in very preterm neonates. In this single-centre, open-label randomized controlled trial at a tertiary-care hospital in Eastern India, neonates born at 26⁺⁰-31⁺⁶ weeks' gestation requiring delivery-room resuscitation were randomized (1:1) to ICR until physiological placental expulsion or conventional cord clamping (CCC) within 30-60 s of birth. The primary outcome was a composite of in-hospital mortality, severe intraventricular haemorrhage (IVH), or bronchopulmonary dysplasia. Secondary outcomes included delivery-room stabilization, maternal safety, and other neonatal morbidities. Analyses followed a per-protocol approach. A total of 127 neonates were analysed (ICR, n = 64; CCC, n = 63). Median (IQR) cord attachment duration was 330 (240-480) seconds in the ICR group and 60 (45-60) seconds in the CCC group. The composite adverse outcome was less frequent with ICR than CCC (35.9% vs 60.3%), corresponding to an absolute risk reduction of 24.4%. Mortality (26.6% vs 41.3%) and severe IVH (9.4% vs 20.6%) were also lower with ICR. ICR was associated with higher Apgar scores, improved oxygenation, reduced positive-pressure ventilation needs, earlier spontaneous respiration, lower sepsis and retinopathy of prematurity rates, higher haemoglobin at 72 h, earlier full enteral feeds, and shorter oxygen therapy. Maternal safety outcomes were comparable between groups. ICR may be a promising strategy to improve early cardiopulmonary stabilization and reduce adverse neonatal outcomes in very preterm infants. CTRI/2025/10/096001; Registration date October 13, 2025. • Cord clamping before completion of cardiopulmonary transition may adversely affect haemodynamic stability and clinical outcomes in very preterm infants. • Intact cord resuscitation (ICR) permits stabilisation while maintaining placental circulation, but evidence regarding its efficacy and safety in very preterm neonates remains limited. • ICR reduced the composite adverse outcome including mortality and, severe intraventricular haemorrhage. • ICR improved delivery-room stabilisation, reduced positive-pressure ventilation requirements, and increased haemoglobin concentration at 72 h.