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Randomised trial of cord clamping at very preterm birth: outcomes at 2 years

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posted on 19.05.2020, 15:02 by L Armstrong-Buisseret, K Powers, J Dorling, L Bradshaw, S Johnson, E Mitchell, L Duley
Objective: To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth. Design: Parallel group randomised (1:1) trial. Setting: Eight UK tertiary maternity units. Participants: Two hundred and seventy six babies born to 261 women expected to have a livebirth before 32+0 weeks gestation. Interventions: Deferred cord clamping (≥2 minutes) and immediate neonatal care with cord intact, or immediate (≤20 seconds) clamping and immediate neonatal care after clamping. Main outcome measure: Composite of death or adverse neurodevelopmental outcome at 2 years corrected age. Results: Six babies born after 35+6 weeks were excluded. At 2 years corrected age, outcome data were not available for a further 52 children, leaving 218 for analysis (115 deferred clamping, 103 immediate clamping). Overall, 24/115 (21%) children allocated deferred clamping died or had an adverse neurodevelopmental outcome compared with 35/103 (34%) allocated immediate clamping; relative risk (RR) 0.61 (95% confidence interval [CI] 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave a RR 0.69 (95% CI 0.44 to 1.09) and RD -9% (95% CI -21% to 2%). Conclusions: Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature. Confirmation in larger studies is needed to determine the real benefits and harms.

Funding

This trial is independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RPPG0609-10107).

History

Citation

Armstrong-Buisseret L, Powers K, Dorling J, et al Randomised trial of cord clamping at very preterm birth: outcomes at 2 years Archives of Disease in Childhood - Fetal and Neonatal Edition 2020;105:292-298.

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences

Version

VoR (Version of Record)

Published in

Archives of Disease in Childhood - Fetal and Neonatal Edition

Volume

105

Pagination

292-298

Publisher

BMJ Publishing Group for Royal College of Paediatrics and Child Health, European Academy of Paediatrics

issn

0003-9888

Acceptance date

17/07/2019

Copyright date

2019

Available date

01/08/2019

Publisher version

https://fn.bmj.com/content/105/3/292

Notes

Patient level data and the dataset presented here are available from the corresponding author. Participant consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.

Language

en

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