Evidence map›Paper›PMID 38439024›Full record

Trial reportTrials2024

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-statistical analysis plan for a multicenter randomized controlled trial.

Sten P Willemsen, Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L J DeKoninck, Enrico Lopriore, Wes Onland, Willem P de Boode, Anton H van Kaam, Debbie H Nuytemans and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03808051 (Physiological-based Cord Clamping in Very Preterm Infants), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03808051 nacompletednot on this map

Physiological-based Cord Clamping in Very Preterm Infants: a Multicentre Randomised Controlled Trial.

TypeinterventionalSponsorLeiden University Medical CenterRan2019 to 2025Enrolled689ConditionsPreterm Infant, Birth, PretermArmsPhysiological-based cord clamping, Time-based cord clamping
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Necrotizing enterocolitis.Nature reviews. Disease primers · 2026
    Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 2 countries.

Sten P WillemsenDepartment of Intensive Care Neonatology and Children, Division of Neonatology, Sophia Children's Hospital, Erasmus MC University Medical Center, P.O. Box 2060, Rotterdam, 3000 CB, The Netherlands.
Ronny KnolDepartment of Intensive Care Neonatology and Children, Division of Neonatology, Sophia Children's Hospital, Erasmus MC University Medical Center, P.O. Box 2060, Rotterdam, 3000 CB, The Netherlands. r.knol@erasmusmc.nl.ORCID http://orcid.org/0000-0003-2436-3343
Emma BrouwerDepartment of Pediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, The Netherlands.
Thomas van den AkkerDepartment of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
Philip L J DeKoninckDepartment of Obstetrics and Gynaecology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Enrico LoprioreDepartment of Pediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, The Netherlands.
Wes OnlandDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Willem P de BoodeDepartment of Pediatrics, Division of Neonatology, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, The Netherlands.
Anton H van KaamDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Debbie H NuytemansDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Irwin K M ReissDepartment of Intensive Care Neonatology and Children, Division of Neonatology, Sophia Children's Hospital, Erasmus MC University Medical Center, P.O. Box 2060, Rotterdam, 3000 CB, The Netherlands.
G Jeroen HuttenDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Sandra A PrinsDepartment of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Estelle E M MulderDepartment of Neonatology, Isala Women and Children's Hospital, Zwolle, The Netherlands.
Christian V HulzebosDepartment of Pediatrics, Division of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.
Sam J van SambeeckDepartment of Pediatrics, Maxima Medical Center, Veldhoven, The Netherlands.
Mayke E van der PuttenDepartment of Pediatrics, Maastricht University Medical Center, Maastricht, The Netherlands.
Inge A ZonnenbergDepartment of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Arjan B Te PasDepartment of Pediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, The Netherlands.
Marijn J VermeulenDepartment of Intensive Care Neonatology and Children, Division of Neonatology, Sophia Children's Hospital, Erasmus MC University Medical Center, P.O. Box 2060, Rotterdam, 3000 CB, The Netherlands.
Emma Kinderziekenhuis · NLLeiden University Medical Center · NLErasmus MC · NLRadboud University Nijmegen · NLIsala · NLMaastricht University · NLUniversity Medical Center Groningen · NLUniversity Medical Center Utrecht · NL

Funding

ZonMw 852001902
6 · The paper itself

Abstract

backgroundMortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC.

methodsThe ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent. The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years. To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data. DISCUSSION: The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.

trial registrationClinicalTrials.gov NCT03808051. Registered on 17 January 2019.

Indexed as

Infant, PrematurePremature BirthChild, PreschoolConstrictionFemaleHumansInfantInfant, NewbornInfant, Very Low Birth WeightRespirationCord clampingPhysiological-based cord clampingPreterm infantsRandomized clinical trialStatistical Analysis Plan

Identifiers

PMID38439024
PMCPMC10913647
OpenAlexW4392381901

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.