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

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

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 < .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.

Conclusions: This 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 registration: Clinicaltrials.gov NCT02727517, 2016/4/4.

Keywords: Apgar score; Cord clamping; Pulse oximetry; Resuscitation; Term newborn; Umbilical cord.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Image of a bed in the delivery department
Fig. 2
Fig. 2
Image of the resuscitation table in a room next to the delivery room. The corresponding author standing beside it
Fig. 3
Fig. 3
Trial profile. Flow diagram adapted from the CONSORT flow diagram (http://www.consort-statement.org/)
Fig. 4
Fig. 4
Outcome on categorical variables after resuscitation with an intact cord versus early cord clamping. P-value calculated using Fischer’s exact test

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