Randomised trial of cord clamping at very preterm birth: outcomes at 2 years
Randomised trial of cord clamping at very preterm birth: outcomes at 2 years
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 live birth before 32 +0 weeks' gestation. Interventions Deferred cord clamping (≥2 min) and immediate neonatal care with cord intact or immediate (≤20 s) 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; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave an 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. Trial registration number ISRCTN21456601.
neonatal care with cord intact, outcomes at 2 years corrected age
F292-F298
Armstrong-Buisseret, Lindsay
dcdb1453-05fa-4a5e-818e-2c9c8a0afc7d
Powers, Katie
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Dorling, Jon
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Bradshaw, Lucy
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Johnson, Samantha
9fa6b368-ae2e-4049-b053-b6a7bdd22561
Mitchell, Eleanor
b6a85891-943e-4cff-87d5-758fddf23d01
Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
Armstrong-Buisseret, Lindsay
dcdb1453-05fa-4a5e-818e-2c9c8a0afc7d
Powers, Katie
4d1b0dce-f773-405f-91b8-cd3b4ec92806
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Bradshaw, Lucy
803184fe-23e7-497c-a1e8-a79d22359c25
Johnson, Samantha
9fa6b368-ae2e-4049-b053-b6a7bdd22561
Mitchell, Eleanor
b6a85891-943e-4cff-87d5-758fddf23d01
Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
Armstrong-Buisseret, Lindsay, Powers, Katie, Dorling, Jon, Bradshaw, Lucy, Johnson, Samantha, Mitchell, Eleanor and Duley, Lelia
(2019)
Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.
Archives of Disease in Childhood: Fetal and Neonatal Edition, 105 (3), .
(doi:10.1136/archdischild-2019-316912).
Abstract
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 live birth before 32 +0 weeks' gestation. Interventions Deferred cord clamping (≥2 min) and immediate neonatal care with cord intact or immediate (≤20 s) 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; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave an 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. Trial registration number ISRCTN21456601.
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More information
Accepted/In Press date: 17 July 2019
e-pub ahead of print date: 1 August 2019
Additional Information:
Funding Information:
The authors would like to thank all children and women who participated in this trial along with their families and the clinical and research staff at the sites. The authors would also like to thank Bernard Schoonakker for participating in the Blinded Endpoint Review Committee along with Gill Gyte (National Childbirth Trust) and Zoe Chivers (Bliss) for their advice and input. This trial is independent research funded by the NIHR under its Programme Grants for Applied Research funding scheme (RPPG0609-10107).
Funding Information:
Funding This trial is independent research funded by the NIHR under its Programme Grants for Applied Research funding scheme (RPPG0609-10107).
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Keywords:
neonatal care with cord intact, outcomes at 2 years corrected age
Identifiers
Local EPrints ID: 485377
URI: http://eprints.soton.ac.uk/id/eprint/485377
ISSN: 1359-2998
PURE UUID: ec83d13c-a580-4c8f-bb69-45fbf8e52c55
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Date deposited: 05 Dec 2023 17:40
Last modified: 18 Mar 2024 04:17
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Contributors
Author:
Lindsay Armstrong-Buisseret
Author:
Katie Powers
Author:
Jon Dorling
Author:
Lucy Bradshaw
Author:
Samantha Johnson
Author:
Eleanor Mitchell
Author:
Lelia Duley
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