Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial
Knol, Ronny; Brouwer, Emma; Akker van den, Thomas; DeKoninck, Philip; Lopriore, Enrico; Onland, W.; Vermeulen, Marijn; Akker van den, Elske; Bodegem van, Leti; de Boode, Willem P; van Kaam, Anton H.; Reiss, Irwin K M; Polglase, Graeme R; Hutten, Jeroen; Prins, Sandra; Mulder, Estelle; Hulzebos, Christiaan V; Samsbeek, Sam Janneke; Putten van der, Mayke; Zonnenberg, Inge; Hooper, Stuart B; Pas te, Arjan
(2022) Trials [E], volume 23, issue 1
(Article)
Abstract
Background: International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However, clamping the cord prior to lung aeration may severely limit circulatory adaptation resulting in a reduction in cardiac output and hypoxia. Delaying cord clamping until
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lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) allows for an adequately established pulmonary circulation and results in a more stable circulatory transition. The decline in cardiac output following time-based delayed cord clamping (TBCC) may thus be avoided. We hypothesise that PBCC, compared to TBCC, results in a more stable transition in very preterm infants, leading to improved clinical outcomes. The primary objective is to compare the effect of PBCC on intact survival with TBCC. Methods: The Aeriation, Breathing, Clamping 3 (ABC3) trial is a multicentre randomised controlled clinical trial. In the interventional PBCC group, the umbilical cord is clamped after the infant is stabilised, defined as reaching heart rate > 100 bpm and SpO 2 > 85% while using supplemental oxygen < 40%. In the control TBCC group, cord clamping is time based at 30–60 s. The primary outcome is survival without major cerebral and/or intestinal injury. Preterm infants born before 30 weeks of gestation are included after prenatal parental informed consent. The required sample size is 660 infants. Discussion: The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management in very preterm infants at birth. Trial registration: ClinicalTrials.gov NCT03808051. First registered on January 17, 2019.
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Keywords: Cord clamping, Physiological-based cord clamping, Preterm infants, Randomised clinical trial, Study protocol, Cord clamping, Pharmacology (medical), Medicine (miscellaneous)
ISSN: 1745-6215
Publisher: BioMed Central
Note: Funding Information: The trial is funded by The Netherlands Organisation for Health Research and Development (project number 852001902). AtP is a recipient of an NWO innovational research incentives scheme (VIDI 91716428). RK received a grant from the Sophia Children’s Hospital Foundation (Rotterdam, S17-14). This project was sponsored by the Gisela Thier Fund (Leiden). Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)