Randomised trial of cord clamping and initial stabilisation at very preterm birth

Duley, Lelia; Dorling, Jon; Pushpa-Rajah, Angela; Oddie, Sam J.; Yoxall, Charles William; Schoonakker, Bernard; Bradshaw, Lucy; Mitchell, Eleanor J.; Fawke, Joe Anthony

Abstract

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. OBJECTIVES: For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care.DESIGN: Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes.SETTING: Eight UK tertiary maternity units.PARTICIPANTS: 261 women expected to have a live birth before 32 weeks, and their 276 babies.INTERVENTIONS: Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping.MAIN OUTCOME MEASURES: Intraventricular haemorrhage (IVH), death before discharge.RESULTS: 132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35+6 weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers.CONCLUSIONS: This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.TRIAL REGISTRATION: ISRCTN 21456601.

Citation

Duley, L., Dorling, J., Pushpa-Rajah, A., Oddie, S. J., Yoxall, C. W., Schoonakker, B., …Fawke, J. A. (2018). Randomised trial of cord clamping and initial stabilisation at very preterm birth. Archives of Disease in Childhood. Fetal and Neonatal Edition, 103(1), F6-F14. https://doi.org/10.1136/archdischild-2016-312567

• Journal Article Type: Article
• Acceptance Date: Jun 23, 2017
• Online Publication Date: Sep 18, 2017
• Publication Date: Jan 1, 2018
• Deposit Date: Jun 28, 2018
• Publicly Available Date: Nov 20, 2018
• Journal: Archives of disease in childhood. Fetal and neonatal edition
• Electronic ISSN: 1468-2052
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 103
• Issue: 1
• Pages: F6-F14
• DOI: https://doi.org/10.1136/archdischild-2016-312567
• Public URL: https://nottingham-repository.worktribe.com/output/1126302
• Publisher URL: https://fn.bmj.com/content/103/1/F6