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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.

ABSTRACT: Background: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). Methods:Randomized 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. Results:At 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?

SUBMITTER: Andersson O

PROVIDER: S-EPMC6714434 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Andersson Ola O Rana Nisha N Ewald Uwe U Målqvist Mats M Stripple Gunilla G Basnet Omkar O Subedi Kalpana K Kc Ashish A

Maternal health, neonatology and perinatology 20190829

<h4>Background</h4>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 ...[more]

PMID: 31485335

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Project description:Background: Preterm newborns receiving briefly delayed cord clamping or cord milking at birth have better neonatal outcomes. However, the time frame in which both these procedures are performed (< 60 s of life) is too short to explore the possible beneficial effects on early infant postnatal adaptation and outcomes of a prolonged transfusion strategy associated with neonatal respiration. Methods and Design: We have designed a randomized, multicenter, controlled two-phase study: phase 1 to assess the feasibility of carrying out the protocol in a large randomized trial, and phase 2 to assess the efficacy of bedside assistance with intact placental circulation for 3 min in comparison to cord milking to improve outcome in the neonatal period; we present here the feasibility and safety phase of the study. Outcomes included feasibility (recruitment rate of two patients per month, compliance with the trial interventions, completeness of data collection, >90% of infants receiving echographic assessments in the first 24 h) and safety variables (5 min Apgar score, delivery room intubation rate, CRIB II score, admission temperature, maximum hemoglobin concentration and hematocrit in the first 24 h and maximum serum bilirubin value) in the two study groups. We also evaluated the same safety variables in infants delivered during the study period but not recruited. Results: A total of 40 infants were enrolled. In all cases the protocol was completed and all feasibility outcomes were reached. Infants assisted with an intact placental circulation have a higher 5 min Apgar score but their admission temperature was lower than milked infants. Delivery room intubation rate, CRIB II score and peak serum bilirubin value were comparable in both groups. Infants who were not subjected to a placental transfusion strategy (excluded patients) had a higher delivery room intubation rate with respect to both study groups. Conclusion: Delaying cord clamping until 3 min of life was challenging but feasible and appeared to be safe. However, admission temperature must be strictly monitored and a more efficacious warming system could be implemented to prevent hypothermia during the procedure. Trial Registration: Clinicaltrials,gov NCT02671305 (date of registration: 26 JAN 2016). https://clinicaltrials.gov/ct2/show/NCT02671305.

Dataset Information

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.

Publications

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.

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