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

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 reducti...

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Autores principales: Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L. J., Lopriore, Enrico, Onland, Wes, Vermeulen, Marijn J., van den Akker–van Marle, M. Elske, van Bodegom–Vos, Leti, de Boode, Willem P., van Kaam, Anton H., Reiss, Irwin K. M., Polglase, Graeme R., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E. M., Hulzebos, Christian V., van Sambeeck, Sam J., van der Putten, Mayke E., Zonnenberg, Inge A., Hooper, Stuart B., te Pas, Arjan B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9526936/
https://www.ncbi.nlm.nih.gov/pubmed/36183143
http://dx.doi.org/10.1186/s13063-022-06789-6
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author Knol, Ronny
Brouwer, Emma
van den Akker, Thomas
DeKoninck, Philip L. J.
Lopriore, Enrico
Onland, Wes
Vermeulen, Marijn J.
van den Akker–van Marle, M. Elske
van Bodegom–Vos, Leti
de Boode, Willem P.
van Kaam, Anton H.
Reiss, Irwin K. M.
Polglase, Graeme R.
Hutten, G. Jeroen
Prins, Sandra A.
Mulder, Estelle E. M.
Hulzebos, Christian V.
van Sambeeck, Sam J.
van der Putten, Mayke E.
Zonnenberg, Inge A.
Hooper, Stuart B.
te Pas, Arjan B.
author_facet Knol, Ronny
Brouwer, Emma
van den Akker, Thomas
DeKoninck, Philip L. J.
Lopriore, Enrico
Onland, Wes
Vermeulen, Marijn J.
van den Akker–van Marle, M. Elske
van Bodegom–Vos, Leti
de Boode, Willem P.
van Kaam, Anton H.
Reiss, Irwin K. M.
Polglase, Graeme R.
Hutten, G. Jeroen
Prins, Sandra A.
Mulder, Estelle E. M.
Hulzebos, Christian V.
van Sambeeck, Sam J.
van der Putten, Mayke E.
Zonnenberg, Inge A.
Hooper, Stuart B.
te Pas, Arjan B.
author_sort Knol, Ronny
collection PubMed
description 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 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06789-6.
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spelling pubmed-95269362022-10-03 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 van den Akker, Thomas DeKoninck, Philip L. J. Lopriore, Enrico Onland, Wes Vermeulen, Marijn J. van den Akker–van Marle, M. Elske van Bodegom–Vos, Leti de Boode, Willem P. van Kaam, Anton H. Reiss, Irwin K. M. Polglase, Graeme R. Hutten, G. Jeroen Prins, Sandra A. Mulder, Estelle E. M. Hulzebos, Christian V. van Sambeeck, Sam J. van der Putten, Mayke E. Zonnenberg, Inge A. Hooper, Stuart B. te Pas, Arjan B. Trials Study Protocol 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 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06789-6. BioMed Central 2022-10-01 /pmc/articles/PMC9526936/ /pubmed/36183143 http://dx.doi.org/10.1186/s13063-022-06789-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Knol, Ronny
Brouwer, Emma
van den Akker, Thomas
DeKoninck, Philip L. J.
Lopriore, Enrico
Onland, Wes
Vermeulen, Marijn J.
van den Akker–van Marle, M. Elske
van Bodegom–Vos, Leti
de Boode, Willem P.
van Kaam, Anton H.
Reiss, Irwin K. M.
Polglase, Graeme R.
Hutten, G. Jeroen
Prins, Sandra A.
Mulder, Estelle E. M.
Hulzebos, Christian V.
van Sambeeck, Sam J.
van der Putten, Mayke E.
Zonnenberg, Inge A.
Hooper, Stuart B.
te Pas, Arjan B.
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title_full Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title_fullStr Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title_full_unstemmed Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title_short Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
title_sort physiological-based cord clamping in very preterm infants: the aeration, breathing, clamping 3 (abc3) trial—study protocol for a multicentre randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9526936/
https://www.ncbi.nlm.nih.gov/pubmed/36183143
http://dx.doi.org/10.1186/s13063-022-06789-6
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