Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial

Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial

Physiological-based cord clamping (PBCC) in preterm infants is beneficial for cardiovascular transition at birth and may optimize placental transfusion. Whether PBCC can improve clinical outcomes is unknown. The aim of the Aeration, Breathing, Clamping (ABC3) trial was to test whether PBCC results i...

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Veröffentlicht in:The Lancet regional health. Europe 2025-01, Vol.48, p.101146, Article 101146
Hauptverfasser: Knol, Ronny, Brouwer, Emma, van den Akker, Thomas, DeKoninck, Philip L.J., Onland, Wes, Vermeulen, Marijn J., de Boode, Willem P., van Kaam, Anton H., Lopriore, Enrico, Reiss, Irwin K.M., Hutten, G. Jeroen, Prins, Sandra A., Mulder, Estelle E.M., d’Haens, Esther J., Hulzebos, Christian V., Bouma, Helene A., van Sambeeck, Sam J., Niemarkt, Hendrik J., van der Putten, Mayke E., Lebon, Tinta, Zonnenberg, Inge A., Nuytemans, Debbie H., Willemsen, Sten P., Polglase, Graeme R., Steggerda, Sylke J., Hooper, Stuart B., te Pas, Arjan B.
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Cord clamping
Newborn resuscitation
Preterm infants
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container_title The Lancet regional health. Europe
container_volume 48
creator Knol, Ronny
Brouwer, Emma
van den Akker, Thomas
DeKoninck, Philip L.J.
Onland, Wes
Vermeulen, Marijn J.
de Boode, Willem P.
van Kaam, Anton H.
Lopriore, Enrico
Reiss, Irwin K.M.
Hutten, G. Jeroen
Prins, Sandra A.
Mulder, Estelle E.M.
d’Haens, Esther J.
Hulzebos, Christian V.
Bouma, Helene A.
van Sambeeck, Sam J.
Niemarkt, Hendrik J.
van der Putten, Mayke E.
Lebon, Tinta
Zonnenberg, Inge A.
Nuytemans, Debbie H.
Willemsen, Sten P.
Polglase, Graeme R.
Steggerda, Sylke J.
Hooper, Stuart B.
te Pas, Arjan B.
description Physiological-based cord clamping (PBCC) in preterm infants is beneficial for cardiovascular transition at birth and may optimize placental transfusion. Whether PBCC can improve clinical outcomes is unknown. The aim of the Aeration, Breathing, Clamping (ABC3) trial was to test whether PBCC results in improved intact survival in very preterm infants. The ABC3 trial was a parallel-group, multicentre, randomised, controlled superiority clinical trial conducted in all Dutch tertiary referral centers for perinatal care involving infants born before 30 weeks of gestation. Infants were randomised to either PBCC or time-based delayed cord clamping (TBCC), stratified by gestational age and treatment center. Infants receiving PBCC were stabilised with umbilical cord intact, which was clamped after reaching cardiorespiratory stability (heart rate >100 bpm and SpO2 >85% while supplemental oxygen
doi_str_mv 10.1016/j.lanepe.2024.101146
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Jeroen ; Prins, Sandra A. ; Mulder, Estelle E.M. ; d’Haens, Esther J. ; Hulzebos, Christian V. ; Bouma, Helene A. ; van Sambeeck, Sam J. ; Niemarkt, Hendrik J. ; van der Putten, Mayke E. ; Lebon, Tinta ; Zonnenberg, Inge A. ; Nuytemans, Debbie H. ; Willemsen, Sten P. ; Polglase, Graeme R. ; Steggerda, Sylke J. ; Hooper, Stuart B. ; te Pas, Arjan B.</creator><creatorcontrib>Knol, Ronny ; Brouwer, Emma ; van den Akker, Thomas ; DeKoninck, Philip L.J. ; Onland, Wes ; Vermeulen, Marijn J. ; de Boode, Willem P. ; van Kaam, Anton H. ; Lopriore, Enrico ; Reiss, Irwin K.M. ; Hutten, G. Jeroen ; Prins, Sandra A. ; Mulder, Estelle E.M. ; d’Haens, Esther J. ; Hulzebos, Christian V. ; Bouma, Helene A. ; van Sambeeck, Sam J. ; Niemarkt, Hendrik J. ; van der Putten, Mayke E. ; Lebon, Tinta ; Zonnenberg, Inge A. ; Nuytemans, Debbie H. ; Willemsen, Sten P. ; Polglase, Graeme R. ; Steggerda, Sylke J. ; Hooper, Stuart B. ; te Pas, Arjan B.</creatorcontrib><description>Physiological-based cord clamping (PBCC) in preterm infants is beneficial for cardiovascular transition at birth and may optimize placental transfusion. Whether PBCC can improve clinical outcomes is unknown. The aim of the Aeration, Breathing, Clamping (ABC3) trial was to test whether PBCC results in improved intact survival in very preterm infants. The ABC3 trial was a parallel-group, multicentre, randomised, controlled superiority clinical trial conducted in all Dutch tertiary referral centers for perinatal care involving infants born before 30 weeks of gestation. Infants were randomised to either PBCC or time-based delayed cord clamping (TBCC), stratified by gestational age and treatment center. Infants receiving PBCC were stabilised with umbilical cord intact, which was clamped after reaching cardiorespiratory stability (heart rate &gt;100 bpm and SpO2 &gt;85% while supplemental oxygen &lt;40%). In TBCC the cord was clamped after 30–60 s. The primary outcome was survival without major cerebral injury and/or necrotizing enterocolitis. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT03808051). From January 25, 2019, through October 2, 2022, 669 infants were randomised (median gestational age 27+5 weeks (IQR 26+2–28+6)) and included in the intention-to-treat population. Intact survival occurred in 241 of 339 infants (71.1%) after PBCC, compared with 223 of 330 (67.6%) after TBCC (odds ratio 1.18, 95% CI 0.84–1.66; absolute risk difference 3.1 %points, 95% CI −11.0 to 15.8, p = 0.33). Pre-specified subgroup analysis showed 69.9% intact survival in male infants after PBCC, compared with 61.8% after TBCC (odds ratio 2.32, 95% CI 1.42–3.78, p for interaction 0.026). Secondary outcomes showed fewer red blood cell transfusions after PBCC (rate ratio 0.83, 95% CI 0.75–0.92, p = 0.0003), lower incidence of late-onset sepsis (27.4% versus 33.3%, odds ratio 0.77, 95% CI 0.62–0.95, p = 0.013) and lower admission temperature (36.3 °C versus 36.7 °C, mean difference −0.5, 95% CI −0.8 to −0.3, p &lt; 0.0001). Parents were less anxious (Likert scale 1.52 (SD 0.97) versus 2.23 (SD 1.35); p &lt; 0.001) and more content (Likert scale 4.74 (SD 0.75) versus 4.49 (SD 0.97); p &lt; 0.001) after PBCC. PBCC in very preterm infants did not increase survival without major cerebral injury or necrotizing enterocolitis compared to TBCC in the entire cohort. A possible beneficial effect in male infants requires confirmation from other trials. PBCC was safe to perform and parents reported more contentment and less anxiety. The Netherlands Organization for Health Research and Development.</description><identifier>ISSN: 2666-7762</identifier><identifier>EISSN: 2666-7762</identifier><identifier>DOI: 10.1016/j.lanepe.2024.101146</identifier><identifier>PMID: 39717227</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Cord clamping ; Newborn resuscitation ; Preterm infants</subject><ispartof>The Lancet regional health. 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Jeroen</creatorcontrib><creatorcontrib>Prins, Sandra A.</creatorcontrib><creatorcontrib>Mulder, Estelle E.M.</creatorcontrib><creatorcontrib>d’Haens, Esther J.</creatorcontrib><creatorcontrib>Hulzebos, Christian V.</creatorcontrib><creatorcontrib>Bouma, Helene A.</creatorcontrib><creatorcontrib>van Sambeeck, Sam J.</creatorcontrib><creatorcontrib>Niemarkt, Hendrik J.</creatorcontrib><creatorcontrib>van der Putten, Mayke E.</creatorcontrib><creatorcontrib>Lebon, Tinta</creatorcontrib><creatorcontrib>Zonnenberg, Inge A.</creatorcontrib><creatorcontrib>Nuytemans, Debbie H.</creatorcontrib><creatorcontrib>Willemsen, Sten P.</creatorcontrib><creatorcontrib>Polglase, Graeme R.</creatorcontrib><creatorcontrib>Steggerda, Sylke J.</creatorcontrib><creatorcontrib>Hooper, Stuart B.</creatorcontrib><creatorcontrib>te Pas, Arjan B.</creatorcontrib><title>Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial</title><title>The Lancet regional health. Europe</title><addtitle>Lancet Reg Health Eur</addtitle><description>Physiological-based cord clamping (PBCC) in preterm infants is beneficial for cardiovascular transition at birth and may optimize placental transfusion. Whether PBCC can improve clinical outcomes is unknown. The aim of the Aeration, Breathing, Clamping (ABC3) trial was to test whether PBCC results in improved intact survival in very preterm infants. The ABC3 trial was a parallel-group, multicentre, randomised, controlled superiority clinical trial conducted in all Dutch tertiary referral centers for perinatal care involving infants born before 30 weeks of gestation. Infants were randomised to either PBCC or time-based delayed cord clamping (TBCC), stratified by gestational age and treatment center. Infants receiving PBCC were stabilised with umbilical cord intact, which was clamped after reaching cardiorespiratory stability (heart rate &gt;100 bpm and SpO2 &gt;85% while supplemental oxygen &lt;40%). In TBCC the cord was clamped after 30–60 s. The primary outcome was survival without major cerebral injury and/or necrotizing enterocolitis. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT03808051). From January 25, 2019, through October 2, 2022, 669 infants were randomised (median gestational age 27+5 weeks (IQR 26+2–28+6)) and included in the intention-to-treat population. Intact survival occurred in 241 of 339 infants (71.1%) after PBCC, compared with 223 of 330 (67.6%) after TBCC (odds ratio 1.18, 95% CI 0.84–1.66; absolute risk difference 3.1 %points, 95% CI −11.0 to 15.8, p = 0.33). Pre-specified subgroup analysis showed 69.9% intact survival in male infants after PBCC, compared with 61.8% after TBCC (odds ratio 2.32, 95% CI 1.42–3.78, p for interaction 0.026). Secondary outcomes showed fewer red blood cell transfusions after PBCC (rate ratio 0.83, 95% CI 0.75–0.92, p = 0.0003), lower incidence of late-onset sepsis (27.4% versus 33.3%, odds ratio 0.77, 95% CI 0.62–0.95, p = 0.013) and lower admission temperature (36.3 °C versus 36.7 °C, mean difference −0.5, 95% CI −0.8 to −0.3, p &lt; 0.0001). Parents were less anxious (Likert scale 1.52 (SD 0.97) versus 2.23 (SD 1.35); p &lt; 0.001) and more content (Likert scale 4.74 (SD 0.75) versus 4.49 (SD 0.97); p &lt; 0.001) after PBCC. PBCC in very preterm infants did not increase survival without major cerebral injury or necrotizing enterocolitis compared to TBCC in the entire cohort. A possible beneficial effect in male infants requires confirmation from other trials. PBCC was safe to perform and parents reported more contentment and less anxiety. 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Jeroen</au><au>Prins, Sandra A.</au><au>Mulder, Estelle E.M.</au><au>d’Haens, Esther J.</au><au>Hulzebos, Christian V.</au><au>Bouma, Helene A.</au><au>van Sambeeck, Sam J.</au><au>Niemarkt, Hendrik J.</au><au>van der Putten, Mayke E.</au><au>Lebon, Tinta</au><au>Zonnenberg, Inge A.</au><au>Nuytemans, Debbie H.</au><au>Willemsen, Sten P.</au><au>Polglase, Graeme R.</au><au>Steggerda, Sylke J.</au><au>Hooper, Stuart B.</au><au>te Pas, Arjan B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial</atitle><jtitle>The Lancet regional health. Europe</jtitle><addtitle>Lancet Reg Health Eur</addtitle><date>2025-01</date><risdate>2025</risdate><volume>48</volume><spage>101146</spage><pages>101146-</pages><artnum>101146</artnum><issn>2666-7762</issn><eissn>2666-7762</eissn><abstract>Physiological-based cord clamping (PBCC) in preterm infants is beneficial for cardiovascular transition at birth and may optimize placental transfusion. Whether PBCC can improve clinical outcomes is unknown. The aim of the Aeration, Breathing, Clamping (ABC3) trial was to test whether PBCC results in improved intact survival in very preterm infants. The ABC3 trial was a parallel-group, multicentre, randomised, controlled superiority clinical trial conducted in all Dutch tertiary referral centers for perinatal care involving infants born before 30 weeks of gestation. Infants were randomised to either PBCC or time-based delayed cord clamping (TBCC), stratified by gestational age and treatment center. Infants receiving PBCC were stabilised with umbilical cord intact, which was clamped after reaching cardiorespiratory stability (heart rate &gt;100 bpm and SpO2 &gt;85% while supplemental oxygen &lt;40%). In TBCC the cord was clamped after 30–60 s. The primary outcome was survival without major cerebral injury and/or necrotizing enterocolitis. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT03808051). From January 25, 2019, through October 2, 2022, 669 infants were randomised (median gestational age 27+5 weeks (IQR 26+2–28+6)) and included in the intention-to-treat population. Intact survival occurred in 241 of 339 infants (71.1%) after PBCC, compared with 223 of 330 (67.6%) after TBCC (odds ratio 1.18, 95% CI 0.84–1.66; absolute risk difference 3.1 %points, 95% CI −11.0 to 15.8, p = 0.33). Pre-specified subgroup analysis showed 69.9% intact survival in male infants after PBCC, compared with 61.8% after TBCC (odds ratio 2.32, 95% CI 1.42–3.78, p for interaction 0.026). Secondary outcomes showed fewer red blood cell transfusions after PBCC (rate ratio 0.83, 95% CI 0.75–0.92, p = 0.0003), lower incidence of late-onset sepsis (27.4% versus 33.3%, odds ratio 0.77, 95% CI 0.62–0.95, p = 0.013) and lower admission temperature (36.3 °C versus 36.7 °C, mean difference −0.5, 95% CI −0.8 to −0.3, p &lt; 0.0001). Parents were less anxious (Likert scale 1.52 (SD 0.97) versus 2.23 (SD 1.35); p &lt; 0.001) and more content (Likert scale 4.74 (SD 0.75) versus 4.49 (SD 0.97); p &lt; 0.001) after PBCC. PBCC in very preterm infants did not increase survival without major cerebral injury or necrotizing enterocolitis compared to TBCC in the entire cohort. A possible beneficial effect in male infants requires confirmation from other trials. PBCC was safe to perform and parents reported more contentment and less anxiety. The Netherlands Organization for Health Research and Development.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>39717227</pmid><doi>10.1016/j.lanepe.2024.101146</doi><orcidid>https://orcid.org/0000-0003-4368-6519</orcidid><orcidid>https://orcid.org/0000-0003-4030-7085</orcidid><orcidid>https://orcid.org/0000-0001-9686-8186</orcidid><orcidid>https://orcid.org/0000-0002-0844-7208</orcidid><orcidid>https://orcid.org/0000-0001-7831-8797</orcidid><orcidid>https://orcid.org/0000-0003-2436-3343</orcidid><oa>free_for_read</oa></addata></record>
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subjects Cord clamping
Newborn resuscitation
Preterm infants
title Physiological versus time based cord clamping in very preterm infants (ABC3): a parallel-group, multicentre, randomised, controlled superiority trial
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