Cord pilot trial: update to randomised trial protocol
Cord pilot trial: update to randomised trial protocol
Background: the Cord Pilot Trial aimed to assess the feasibility of conducting a large UK randomised trial to compare the effects of alternative polices for timing of cord clamping (immediate within 20 seconds or deferred after at least 2 minutes) for very preterm birth before 32 weeks gestation. Initial recruitment was from March 2013 to February 2014, phase 2 was from March 2014 to February 2015. This paper updates the pilot trial protocol (Trials 15(1):258, 2014) and presents the changes for phase 2.
Methods: an electronic randomisation system was introduced at three of the eight pilot sites. For follow-up of children, the Parent Report of Children's Abilities - Revised (PARCA-R) will not be used. For children recruited to the trial during phase 2, follow-up at age 2 years (corrected for gestation at birth) will be by parent completed Ages and Stages Questionnaire (Squire J, Ages and Stages Questionnaires (ASQ), 2009) alone unless funds can be secured for the additional Bayley Scales of Infant Development III (Bayley N, Bayley Scales of Infant and Toddler Development, Third Edition. (Bayley-III), 2005) assessments. To assess accuracy of the cranial ultrasound diagnosis of intraventricular haemorrhage: (i) quality of the scans will be assessed using the British Society of Paediatric Radiology recommendations, and (ii) scan results will be confirmed by independent adjudication. Within and between adjudicator reliability will be assessed. In addition to the analyses planned to assess feasibility of the full trial based on data from the first year of recruitment, data on compliance and outcomes will be presented by allocated group for all women and babies recruited.
Trial registration: ISRCTN21456601, registered on 28 February 2013.
Neonatal care at the bedside, Pilot, Preterm birth, Randomised trial, Umbilical cord clamping
Bradshaw, Lucy E.
4efb4747-f146-4816-b06e-982bf895c6a3
Pushpa-Rajah, Angela
0defd24d-bac4-4422-a6bb-358594dae4a3
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Mitchell, Eleanor J.
f7d8ce2d-e847-44c7-95af-4076be358af8
Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
and on behalf of the Cord Pilot Trial Collaborative Group
Bradshaw, Lucy E.
4efb4747-f146-4816-b06e-982bf895c6a3
Pushpa-Rajah, Angela
0defd24d-bac4-4422-a6bb-358594dae4a3
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Mitchell, Eleanor J.
f7d8ce2d-e847-44c7-95af-4076be358af8
Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
Bradshaw, Lucy E., Pushpa-Rajah, Angela and Dorling, Jon
,
and on behalf of the Cord Pilot Trial Collaborative Group
(2015)
Cord pilot trial: update to randomised trial protocol.
Trials, 16 (1), [407].
(doi:10.1186/s13063-015-0936-2).
Abstract
Background: the Cord Pilot Trial aimed to assess the feasibility of conducting a large UK randomised trial to compare the effects of alternative polices for timing of cord clamping (immediate within 20 seconds or deferred after at least 2 minutes) for very preterm birth before 32 weeks gestation. Initial recruitment was from March 2013 to February 2014, phase 2 was from March 2014 to February 2015. This paper updates the pilot trial protocol (Trials 15(1):258, 2014) and presents the changes for phase 2.
Methods: an electronic randomisation system was introduced at three of the eight pilot sites. For follow-up of children, the Parent Report of Children's Abilities - Revised (PARCA-R) will not be used. For children recruited to the trial during phase 2, follow-up at age 2 years (corrected for gestation at birth) will be by parent completed Ages and Stages Questionnaire (Squire J, Ages and Stages Questionnaires (ASQ), 2009) alone unless funds can be secured for the additional Bayley Scales of Infant Development III (Bayley N, Bayley Scales of Infant and Toddler Development, Third Edition. (Bayley-III), 2005) assessments. To assess accuracy of the cranial ultrasound diagnosis of intraventricular haemorrhage: (i) quality of the scans will be assessed using the British Society of Paediatric Radiology recommendations, and (ii) scan results will be confirmed by independent adjudication. Within and between adjudicator reliability will be assessed. In addition to the analyses planned to assess feasibility of the full trial based on data from the first year of recruitment, data on compliance and outcomes will be presented by allocated group for all women and babies recruited.
Trial registration: ISRCTN21456601, registered on 28 February 2013.
Text
s13063-015-0936-2 (1)
- Version of Record
More information
Accepted/In Press date: 1 September 2015
e-pub ahead of print date: 14 September 2015
Additional Information:
Funding information:
The Cord Pilot Trial is independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-0609-10107).
Keywords:
Neonatal care at the bedside, Pilot, Preterm birth, Randomised trial, Umbilical cord clamping
Identifiers
Local EPrints ID: 485033
URI: http://eprints.soton.ac.uk/id/eprint/485033
ISSN: 1745-6215
PURE UUID: f02f8b75-96ef-496a-ba33-713ac29ed330
Catalogue record
Date deposited: 28 Nov 2023 17:50
Last modified: 18 Mar 2024 04:16
Export record
Altmetrics
Contributors
Author:
Lucy E. Bradshaw
Author:
Angela Pushpa-Rajah
Author:
Jon Dorling
Author:
Eleanor J. Mitchell
Author:
Lelia Duley
Corporate Author: and on behalf of the Cord Pilot Trial Collaborative Group
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics