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 ZonnenbergStuart B Hooper, Arjan B Te Pas

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Article number838
Number of pages13
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - 1 Oct 2022

Keywords

  • Constriction
  • Female
  • Fetal Growth Retardation
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature
  • Infant, Very Low Birth Weight
  • Multicenter Studies as Topic
  • Oxygen
  • Pregnancy
  • Randomized Controlled Trials as Topic
  • Umbilical Cord/surgery

Cite this