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

Objectives: For very preterm births, to compare alternatives 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...

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Main Authors: Duley, Lelia, Dorling, Jon, Pushpa-Rajah, Angela, Oddie, Sam J., Yoxall, Charles W., Schoonakker, Bernard, Bradshaw, Lucy, Mitchell, Eleanor J., Fawke, Joe
Format: Article
Published: BMJ 2017
Subjects:
Online Access:https://eprints.nottingham.ac.uk/44309/
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author Duley, Lelia
Dorling, Jon
Pushpa-Rajah, Angela
Oddie, Sam J.
Yoxall, Charles W.
Schoonakker, Bernard
Bradshaw, Lucy
Mitchell, Eleanor J.
Fawke, Joe
author_facet Duley, Lelia
Dorling, Jon
Pushpa-Rajah, Angela
Oddie, Sam J.
Yoxall, Charles W.
Schoonakker, Bernard
Bradshaw, Lucy
Mitchell, Eleanor J.
Fawke, Joe
author_sort Duley, Lelia
building Nottingham Research Data Repository
collection Online Access
description Objectives: For very preterm births, to compare alternatives 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 livebirth before 32 weeks, and their 276 babies. Interventions: Cord clamping after at least two minutes and immediate neonatal care with cord intact, or clamping within 20 seconds and immediate neonatal care after clamping. Main outcome measures: Intraventricular haemorrhage (IVH), death before discharge. Results: 132 women (137 babies) were allocated clamping ≥2 minutes and neonatal care cord intact, and 129 (139) clamping ≤20 and neonatal care after clamping; 6 mother infant dyads were excluded (2, 4) as birth was after 35+6 weeks, 1 withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 minutes, and 29.2 for those allocated clamping ≤20 seconds. Median time to clamping was 120 and 11 seconds respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 minutes died and 15 of 135 (11.1%) allocated clamping ≤20 seconds; risk difference (RD) -5.9% (95% confidence interval -12.4% to 0.6%). Of livebirths, 43 of 134 (32%) had IVH versus 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 minutes and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.
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spelling nottingham-443092020-05-04T19:22:32Z https://eprints.nottingham.ac.uk/44309/ Randomised trial of cord clamping and initial stabilisation at very preterm birth Duley, Lelia Dorling, Jon Pushpa-Rajah, Angela Oddie, Sam J. Yoxall, Charles W. Schoonakker, Bernard Bradshaw, Lucy Mitchell, Eleanor J. Fawke, Joe Objectives: For very preterm births, to compare alternatives 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 livebirth before 32 weeks, and their 276 babies. Interventions: Cord clamping after at least two minutes and immediate neonatal care with cord intact, or clamping within 20 seconds and immediate neonatal care after clamping. Main outcome measures: Intraventricular haemorrhage (IVH), death before discharge. Results: 132 women (137 babies) were allocated clamping ≥2 minutes and neonatal care cord intact, and 129 (139) clamping ≤20 and neonatal care after clamping; 6 mother infant dyads were excluded (2, 4) as birth was after 35+6 weeks, 1 withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 minutes, and 29.2 for those allocated clamping ≤20 seconds. Median time to clamping was 120 and 11 seconds respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 minutes died and 15 of 135 (11.1%) allocated clamping ≤20 seconds; risk difference (RD) -5.9% (95% confidence interval -12.4% to 0.6%). Of livebirths, 43 of 134 (32%) had IVH versus 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 minutes and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed. BMJ 2017-12-13 Article PeerReviewed Duley, Lelia, Dorling, Jon, Pushpa-Rajah, Angela, Oddie, Sam J., Yoxall, Charles W., Schoonakker, Bernard, Bradshaw, Lucy, Mitchell, Eleanor J. and Fawke, Joe (2017) Randomised trial of cord clamping and initial stabilisation at very preterm birth. Archives of Disease in Childhood, 103 (1). F6-F14. ISSN 1468-2044 preterm birth randomised trial cord clamping neonatal care with umbilical cord intact intraventricular haemorrhage http://fn.bmj.com/content/103/1/F6 doi:10.1136/archdischild-2016-312567 doi:10.1136/archdischild-2016-312567
spellingShingle preterm birth
randomised trial
cord clamping
neonatal care with umbilical cord intact
intraventricular haemorrhage
Duley, Lelia
Dorling, Jon
Pushpa-Rajah, Angela
Oddie, Sam J.
Yoxall, Charles W.
Schoonakker, Bernard
Bradshaw, Lucy
Mitchell, Eleanor J.
Fawke, Joe
Randomised trial of cord clamping and initial stabilisation at very preterm birth
title Randomised trial of cord clamping and initial stabilisation at very preterm birth
title_full Randomised trial of cord clamping and initial stabilisation at very preterm birth
title_fullStr Randomised trial of cord clamping and initial stabilisation at very preterm birth
title_full_unstemmed Randomised trial of cord clamping and initial stabilisation at very preterm birth
title_short Randomised trial of cord clamping and initial stabilisation at very preterm birth
title_sort randomised trial of cord clamping and initial stabilisation at very preterm birth
topic preterm birth
randomised trial
cord clamping
neonatal care with umbilical cord intact
intraventricular haemorrhage
url https://eprints.nottingham.ac.uk/44309/
https://eprints.nottingham.ac.uk/44309/
https://eprints.nottingham.ac.uk/44309/