Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10\u2009minutes of birth (Nepcord III) \u2013 a randomized clinical trial

Ola Andersson,Mats Målqvist,Ashish Kc,Omkar Basnet,Uwe Ewald,Nisha Rana,Kalpana Subedi,Gunilla Stripple

doi:10.1186/s40748-019-0110-z

Ola Andersson, Mats Målqvist + Show 6 more

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https://doi.org/10.1186/s40748-019-0110-z

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Abstract

BackgroundExperiments have shown improved cardiovascular stability in lambs if umbilical cord clamping is postponed until positive pressure ventilation is started. Studies on intact cord resuscitation on human term infants are sparse. The purpose of this study was to evaluate differences in clinical outcomes in non-breathing infants between groups, one where resuscitation is initiated with an intact umbilical cord (intervention group) and one group where cord clamping occurred prior to resuscitation (control group).MethodsRandomized controlled trial, inclusion period April to August 2016 performed at a tertiary hospital in Kathmandu, Nepal. Late preterm and term infants born vaginally, non-breathing and in need of resuscitation according to the ‘Helping Babies Breathe’ algorithm were randomized to intact cord resuscitation or early cord clamping before resuscitation. Main outcome measures were saturation by pulse oximetry (SpO2), heart rate and Apgar at 1, 5 and 10 minutes after birth.ResultsAt 10 minutes after birth, SpO2 (SD) was significantly higher in the intact cord group compared to the early cord clamping group, 90.4 (8.1) vs 85.4 (2.7) %, P < .001). In the intact cord group, 57 (44%) had SpO2 < 90% after 10 minutes, compared to 93 (100%) in the early cord clamping group, P < 0.001. SpO2 was also significantly higher in the intervention (intact cord) group at one and five minutes after birth. Heart rate was lower in the intervention (intact cord) group at one and five minutes and slightly higher at ten minutes, all significant findings. Apgar score was significantly higher at one, five and ten minutes. At 5 minutes, 23 (17%) had Apgar score < 7 in the intervention (intact cord) group compared to 26 (27%) in the early cord clamping group, P < .07. Newborn infants in the intervention (intact cord) group started to breathe and establish regular breathing earlier than in the early cord clamping group.ConclusionsThis study provides new and important information on the effects of resuscitation with an intact umbilical cord. The findings of improved SpO2 and higher Apgar score, and the absence of negative consequences encourages further studies with longer follow-up.Trial registrationClinicaltrials.gov NCT02727517, 2016/4/4

Highlights

Experiments have shown improved cardiovascular stability in lambs if umbilical cord clamping is postponed until positive pressure ventilation is started
After signed consent was obtained and as birth was imminent, 780 women were randomly assigned to early cord clamping and 780 to delayed cord clamping where CC occurred after at least 3 minutes subsequent to the appearance of the infant’s shoulder
Of the 1560 included newborns, 1329 were breathing and were excluded, while 231 were assessed as needing resuscitation according to the Helping Babies Breathe (HBB) algorithm, 141 boys (61.0%) and 90 girls (39.0%); mean (SD) gestational age, 39.6 (1.4) weeks

Summary

Introduction

Experiments have shown improved cardiovascular stability in lambs if umbilical cord clamping is postponed until positive pressure ventilation is started. Studies on intact cord resuscitation on human term infants are sparse. The purpose of this study was to evaluate differences in clinical outcomes in non-breathing infants between groups, one where resuscitation is initiated with an intact umbilical cord (intervention group) and one group where cord clamping occurred prior to resuscitation (control group). Two thirds of a million term newborns die worldwide due to intrapartum-related events, the majority due to asphyxia and a disproportionate amount occurring in low-resource countries [1, 2]. Adoption and implementation of the International Liaison Committee on Resuscitation (ILCOR) recommendations vary, and initiatives such as Neonatal Resuscitation Program and Helping Babies Breathe have identified the necessity of training and simulation needed to sustain change [6,7,8]

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