Early or Late Cord Clamping in the Depressed Neonate (NepCordIII)

Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome

This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.

At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth. The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu. The trial will fill several important gaps in relation to early and delayed cord clamping and results.

If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table

If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother

Inclusion Criteria: Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth) Gestational age ≥ 33 weeks Exclusion Criteria: Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation

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Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.

Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.