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

doi:10.1186/s13063-022-06789-6

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 journal › Article › Academic › peer-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 language	English
Article number	838
Number of pages	13
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06789-6
Publication status	Published - 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

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Knol, R., Brouwer, E., van den Akker, T., DeKoninck, P. L. J., Lopriore, E., Onland, W., Vermeulen, M. J., van den Akker-van Marle, M. E., van Bodegom-Vos, L., de Boode, W. P., van Kaam, A. H., Reiss, I. K. M., Polglase, G. R., Hutten, G. J., Prins, S. A., Mulder, E. E. M., Hulzebos, C. V., van Sambeeck, S. J., van der Putten, M. E., ... Te Pas, A. B. (2022). Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial. Trials, 23(1), Article 838. https://doi.org/10.1186/s13063-022-06789-6

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title = "Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial",

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.",

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",

author = "Ronny Knol and Emma Brouwer and {van den Akker}, Thomas and DeKoninck, {Philip L J} and Enrico Lopriore and Wes Onland and Vermeulen, {Marijn J} and {van den Akker-van Marle}, {M Elske} and {van Bodegom-Vos}, Leti and {de Boode}, {Willem P} and {van Kaam}, {Anton H} and Reiss, {Irwin K M} and Polglase, {Graeme R} and Hutten, {G Jeroen} and Prins, {Sandra A} and Mulder, {Estelle E M} and Hulzebos, {Christian V} and {van Sambeeck}, {Sam J} and {van der Putten}, {Mayke E} and Zonnenberg, {Inge A} and Hooper, {Stuart B} and {Te Pas}, {Arjan B}",

note = "{\textcopyright} 2022. The Author(s).",

year = "2022",

month = oct,

day = "1",

doi = "10.1186/s13063-022-06789-6",

language = "English",

volume = "23",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

number = "1",

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Knol, R, Brouwer, E, van den Akker, T, DeKoninck, PLJ, Lopriore, E, Onland, W, Vermeulen, MJ, van den Akker-van Marle, ME, van Bodegom-Vos, L, de Boode, WP, van Kaam, AH, Reiss, IKM, Polglase, GR, Hutten, GJ, Prins, SA, Mulder, EEM, Hulzebos, CV, van Sambeeck, SJ, van der Putten, ME, Zonnenberg, IA, Hooper, SB & Te Pas, AB 2022, 'Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial', Trials, vol. 23, no. 1, 838. https://doi.org/10.1186/s13063-022-06789-6

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

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.

KW - Constriction

KW - Female

KW - Fetal Growth Retardation

KW - Humans

KW - Infant

KW - Infant, Newborn

KW - Infant, Premature

KW - Infant, Very Low Birth Weight

KW - Multicenter Studies as Topic

KW - Oxygen

KW - Pregnancy

KW - Randomized Controlled Trials as Topic

KW - Umbilical Cord/surgery

U2 - 10.1186/s13063-022-06789-6

DO - 10.1186/s13063-022-06789-6

M3 - Article

C2 - 36183143

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 838

ER -

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-study protocol for a multicentre randomised controlled trial

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Keywords

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