Evidence map›Paper›PMID 38509614›Full record

Trial reportTrials2024

Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan.

Emily J J Horn-Oudshoorn, Marijn J Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B Te Pas, Stuart B Hooper, Suzan C M Cochius-den Otter, Rene M H Wijnen, Kelly J Crossley, Neysan Rafat and 11 more

Erratum issued 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. An erratum has been issued. It is linked to trial NCT04373902 (Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia), 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.

NCT04373902 naactive not recruitingnot on this map

Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial

TypeinterventionalSponsorErasmus Medical CenterRan2020 to 2026Enrolled140ConditionsHernias, Diaphragmatic, Congenital, Hernia, Diaphragm Defect, Congenital, Pulmonary HypertensionArmsPhysiological-based cord clamping
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Cardiorespiratory transition in CDH.Seminars in fetal & neonatal medicine · 2025
    Review
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 12 institutions in 8 countries.

Emily J J Horn-OudshoornDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Marijn J VermeulenDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Ronny KnolDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Rebekka Bout-RebelDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Arjan B Te PasDivision of Neonatology, Department of Paediatrics, Leiden University Medical Center, Leiden, the Netherlands.
Stuart B HooperThe Ritchie Centre, Hudson Institute for Medical Research, Monash University, Melbourne, Victory, Australia.
Suzan C M Cochius-den OtterDivision of Paediatric Intensive Care, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Rene M H WijnenDivision of Paediatric Intensive Care, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Kelly J CrossleyThe Ritchie Centre, Hudson Institute for Medical Research, Monash University, Melbourne, Victory, Australia.
Neysan RafatDepartment of Neonatology, University Medical Center Mannheim, Mannheim, Germany.
Thomas SchaibleDepartment of Neonatology, University Medical Center Mannheim, Mannheim, Germany.
Willem P de BoodeDivision of Neonatology, Department of Paediatrics, Radboudumc University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, The Netherlands.
Anne DebeerDepartment of Neonatology, University Hospitals Leuven, Leuven, Belgium.
Berndt UrlesbergerDivision of Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.
Calum T RobertsDepartment of Paediatrics, Monash University, Melbourne, Victoria, Australia.
Florian KipfmuellerDepartment of Neonatology and Paediatric Intensive Care Medicine, University of Bonn Children's Hospital, Bonn, Germany.
Irma CapolupoDepartment of Medical and Surgical Neonatology, Bambino Gesu Children's Hospital, IRCCS, Rome, Italy.
Carmen M BurgosDepartment of Paediatric Surgery, Karolinska University Hospital, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Bettina E HansenDepartment of Epidemiology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Irwin K M ReissDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Philip L J DeKoninckDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC University Medical Center, Rotterdam, the Netherlands. p.dekoninck@erasmusmc.nl.ORCID http://orcid.org/0000-0002-4457-0940
Erasmus MC · NLHeidelberg University · DEHudson Institute of Medical Research · AUBambino Gesù Children's Hospital · ITKarolinska University Hospital · SEKU Leuven · BELeiden University Medical Center · NLMedical University of Graz · ATMonash University · AURadboud University Nijmegen · NLUniversity Health Network · CAUniversity of Bonn · DE

Funding

Stichting Vrienden van het Sophia S19-12
6 · The paper itself

Abstract

backgroundInfants born with congenital diaphragmatic hernia (CDH) are at high risk of respiratory insufficiency and pulmonary hypertension. Routine practice includes immediate clamping of the umbilical cord and endotracheal intubation. Experimental animal studies suggest that clamping the umbilical cord guided by physiological changes and after the lungs have been aerated, named physiological-based cord clamping (PBCC), could enhance the fetal-to-neonatal transition in CDH. We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial).

designThe PinC trial is a multicentre, randomised controlled trial in infants with isolated left-sided CDH, born ≥ 35.0 weeks of gestation. The primary outcome is the incidence of pulmonary hypertension in the first 24 h after birth. Maternal outcomes include estimated maternal blood loss. Neonatal secondary outcomes include mortality before discharge, extracorporeal membrane oxygenation therapy, and number of days of mechanical ventilation. Infants are 1:1 randomised to either PBCC or immediate cord clamping using variable random permutated block sizes (4-8), stratified by treatment centre and estimated severity of pulmonary hypoplasia (i.e. mild/moderate/severe). At least 140 infants are needed to detect a relative reduction in pulmonary hypertension by one third, with 80% power and 0.05 significance level. A chi-square test will be used to evaluate the hypothesis that PBCC decreases the occurrence of pulmonary hypertension. This plan is written and submitted without knowledge of the collected data. The trial has been ethically approved.

trial registrationClinicalTrials.gov NCT04373902 (registered April 2020).

Indexed as

Hernias, Diaphragmatic, CongenitalHypertension, PulmonaryAnimalsConstrictionFemaleHumansInfant, NewbornPregnancyRespiration, ArtificialUmbilical CordUmbilical Cord ClampingCongenital diaphragmatic herniaPulmonary hypertension

Identifiers

PMID38509614
PMCPMC10953116
OpenAlexW4393011211

What OpenQuestion holds

Textmetadata
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.