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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Sectio Caesarea | Update

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Authors: Sten P. Willemsen, Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Willem P. de Boode, Anton H. van Kaam, Debbie H. Nuytemans, Irwin K. M. Reiss, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder, Christian V. Hulzebos, Sam J. van Sambeeck, Mayke E. van der Putten, Inge A. Zonnenberg, Arjan B. te Pas, Marijn J. Vermeulen

Published in: Trials | Issue 1/2024

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Abstract

Background

Mortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC.

Methods

The ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent.
The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years.
To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data.

Discussion

The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.

Trial registration

ClinicalTrials.gov NCT03808051. Registered on 17 January 2019.
Appendix
Available only for authorised users
Literature
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Metadata
Title
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial
Authors
Sten P. Willemsen
Ronny Knol
Emma Brouwer
Thomas van den Akker
Philip L. J. DeKoninck
Enrico Lopriore
Wes Onland
Willem P. de Boode
Anton H. van Kaam
Debbie H. Nuytemans
Irwin K. M. Reiss
G. Jeroen Hutten
Sandra A. Prins
Estelle E. M. Mulder
Christian V. Hulzebos
Sam J. van Sambeeck
Mayke E. van der Putten
Inge A. Zonnenberg
Arjan B. te Pas
Marijn J. Vermeulen
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08014-y

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