Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
Ronny Knol,
Emma Brouwer,
Thomas van den Akker,
Philip L. J. DeKoninck,
Enrico Lopriore,
Wes Onland,
Marijn J. Vermeulen,
M. Elske van den Akker–van Marle,
Leti van Bodegom–Vos,
Willem P. de Boode,
Anton H. van Kaam,
Irwin K. M. Reiss,
Graeme R. Polglase,
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,
Stuart B. Hooper,
Arjan B. te Pas
Affiliations
Ronny Knol
Division of Neonatology, Department of Paediatrics, Sophia Children’s Hospital, Erasmus MC University Medical Center
Emma Brouwer
Division of Neonatology, Department of Paediatrics, Leiden University Medical Center
Thomas van den Akker
Department of Obstetrics, Leiden University Medical Center
Philip L. J. DeKoninck
Department of Obstetrics and Gynaecology, Erasmus MC University Medical Center
Enrico Lopriore
Division of Neonatology, Department of Paediatrics, Leiden University Medical Center
Wes Onland
Department of Neonatology, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam
Marijn J. Vermeulen
Division of Neonatology, Department of Paediatrics, Sophia Children’s Hospital, Erasmus MC University Medical Center
M. Elske van den Akker–van Marle
Department of Biomedical Data Sciences, Leiden University Medical Center
Leti van Bodegom–Vos
Department of Biomedical Data Sciences, Leiden University Medical Center
Willem P. de Boode
Division of Neonatology, Department of Paediatrics, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children’s Hospital
Anton H. van Kaam
Department of Neonatology, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam
Irwin K. M. Reiss
Division of Neonatology, Department of Paediatrics, Sophia Children’s Hospital, Erasmus MC University Medical Center
Graeme R. Polglase
The Ritchie Centre, Hudson Institute of Medical Research, Monash University
G. Jeroen Hutten
Department of Neonatology, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam
Sandra A. Prins
Department of Neonatology, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam
Estelle E. M. Mulder
Department of Neonatology, Isala Women and Children’s Hospital
Christian V. Hulzebos
Department of Paediatrics, Beatrix Children’s Hospital, University Medical Center Groningen
Sam J. van Sambeeck
Department of Paediatrics, Maxima Medical Center
Mayke E. van der Putten
Department of Paediatrics, Maastricht University Medical Center
Inge A. Zonnenberg
Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Center Utrecht
Stuart B. Hooper
The Ritchie Centre, Hudson Institute of Medical Research, Monash University
Arjan B. te Pas
Division of Neonatology, Department of Paediatrics, Leiden University Medical Center
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 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 SpO2 > 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.
