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

doi:10.1186/s40748-019-0110-z

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.

Authors

Ola Andersson¹, Nisha Rana², Uwe Ewald², Mats Målqvist², Gunilla Stripple³, Omkar Basnet⁴, Kalpana Subedi⁵, Ashish Kc²

Affiliations

¹ 1Department of Clinical Sciences Lund, Pediatrics/Neonatology, Skane University Hospital, Lund University, SUS, Barn- & Ungdomssjukh. Avd. Ped, 221 85 Lund, Sweden.
² 2International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
³ Wass Medicin, Lund, Sweden.
⁴ Golden Community, Kathmandu, Nepal.
⁵ Paropakar Maternity and Women's Hospital, Kathmandu, Nepal.

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.

Associated data

ClinicalTrials.gov/NCT02727517