Evidence map›Paper›PMID 39672574›Full record

ArticleBMJ open2024

Does primary posterior tracheopexy prevent collapse of the trachea in newborns with oesophageal atresia and tracheomalacia? A study protocol for an international, multicentre randomised controlled trial (PORTRAIT trial).

Marit J B van Stigt, Anne-Fleur R L van Hal, Arnold J N Bittermann, Colin R Butler, Ilse Ceelie, Daniela Cianci, Paolo de Coppi, Caroline Gahm, Julia E Hut, Koen F M Joosten and 11 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06335862 (Primary pOsterioR TRacheopexy Prevents Collapse of the Trachea in Newborns With Oesophageal AtresIa and Tracheomalacia), 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
–field-weighted citation impact
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.

NCT06335862 naenrolling by invitationnot on this map

Primary pOsterioR TRacheopexy Prevents Collapse of the Trachea in Newborns With Oesophageal AtresIa and Tracheomalacia

TypeinterventionalSponsorUMC UtrechtRan2024 to 2027Enrolled78ConditionsOesophageal Atresia With Tracheo-Oesophageal Fistula, Tracheomalacia, Oesophageal AtresiaArmsRandomisation between the PPT- and no-PPT-group, Primary Posterior Tracheopexy, Preoperative tracheobronchoscopy, Intraoperative tracheobronchoscopy, Postoperative tracheobronchoscopy through the endotracheal tube during extubation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Collaborative Efforts in Pediatric Surgery: Lessons from European Randomized Controlled Trials.European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie · 2025
    Review
  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

21 authors.

Marit J B van Stigt *Congenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands m.j.b.vanstigt-3@umcutrecht.nl.ORCID http://orcid.org/0000-0002-2483-8719
Anne-Fleur R L van Hal *Department of Paediatric Surgery, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
Arnold J N BittermannCongenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.
Colin R ButlerDepartment of Otorhinolaryngology, Great Ormond Street Hospital for Children, London, UK.
Ilse CeelieDepartment of Anaesthesiology, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.
Daniela CianciJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Paolo de CoppiDepartment of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK.
Caroline GahmDivision of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska University Hospital, Stockholm, Sweden.
Julia E HutCongenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.
Koen F M JoostenDepartment of Neonatal and Paediatric Intensive Care, Division of Paediatric Intensive Care, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
Petra M A LemmersDepartment of Neonatology, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.
Dhanya MullasseryDepartment of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK.
Reema NandiDepartment of Anaesthesia, Great Ormond Street Hospital for Children, London, UK.
Bas PullensDepartment of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC - Sophia Children Hospital, Rotterdam, The Netherlands.
Lonneke M StaalsDepartment of Anaesthesiology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
Jan F SvenssonDepartment of Paediatric Surgery, Karolinska University Hospital, Stockholm, Sweden.
Stefaan H A J TytgatCongenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.
Peter M van de VenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
René M H WijnenDepartment of Paediatric Surgery, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
John Vlot *Department of Paediatric Surgery, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
Maud Y A Lindeboom *Congenital Oesophageal and Airway Team Utrecht, Departments of Paediatric Surgery and Otorhinolaryngology and Head and Neck Surgery, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTracheomalacia (TM) often occurs in children with oesophageal atresia (OA), leading to recurrent respiratory symptoms and in severe cases to blue spells or ultimately respiratory arrest. In some patients, a secondary posterior tracheopexy may then be indicated. This secondary surgery, as well as respiratory morbidity, may be prevented by performing a primary posterior tracheopexy (PPT) concurrent with primary OA correction. The aim of this trial is to determine if a PPT can decrease-or prevent-tracheal collapse in newborns with OA and TM. Additionally, the trial aims to determine whether the potential observed effect of PPT on tracheal stability is sustained over time. METHODS AND ANALYSIS: This is an international multicentre double-blind randomised controlled trial. Seventy-eight children with OA type C will be randomised 1:1 into the no-PPT group or PPT group. Randomisation will be stratified by centre. The degree and location of TM are assessed during preoperative, intraoperative and two postoperative tracheobronchoscopies. The occurrence of TM will be evaluated during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages. The difference in the mean degree of collapse will be compared between the no-PPT and the PPT groups using linear regression, adjusting for centre and the preoperative degree of tracheal collapse at baseline. The adjusted mean difference will be reported as effect size together with its 95% CI. ETHICS AND DISSEMINATION: Patients will be included after written parental informed consent. The risks and burden associated with the trial are minimal. The institutional review board of the University Medical Center Utrecht has approved this protocol (METC-number 23-256/A). Results will be shared in a peer-reviewed scientific journal and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT06335862.

Indexed as

Esophageal AtresiaTracheaTracheomalaciaDouble-Blind MethodFemaleHumansInfant, NewbornMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicPaediatric otolaryngologyPaediatric thoracic surgeryRandomized Controlled Trial

Identifiers

PMID39672574
PMCPMC11647280

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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.