TY - JOUR
T1 - Physiological-based cord clamping in very preterm infants
T2 - the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
AU - Knol, Ronny
AU - Brouwer, Emma
AU - van den Akker, Thomas
AU - DeKoninck, Philip L.J.
AU - Lopriore, Enrico
AU - Onland, Wes
AU - Vermeulen, Marijn J.
AU - van den Akker–van Marle, M. Elske
AU - van Bodegom–Vos, Leti
AU - de Boode, Willem P.
AU - van Kaam, Anton H.
AU - Reiss, Irwin K.M.
AU - Polglase, Graeme R.
AU - Hutten, G. Jeroen
AU - Prins, Sandra A.
AU - Mulder, Estelle E.M.
AU - Hulzebos, Christian V.
AU - van Sambeeck, Sam J.
AU - van der Putten, Mayke E.
AU - Zonnenberg, Inge A.
AU - Hooper, Stuart B.
AU - te Pas, Arjan B.
N1 - 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).
PY - 2022/10/1
Y1 - 2022/10/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85139158842&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06789-6
DO - 10.1186/s13063-022-06789-6
M3 - Article
C2 - 36183143
AN - SCOPUS:85139158842
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 838
ER -