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)
René M H Wijnen,
John Vlot,
Petra M A Lemmers,
Bas Pullens,
Dhanya Mullassery,
Paolo De Coppi,
Peter M van de Ven,
Jan F Svensson,
Koen F M Joosten,
Marit J B van Stigt,
Anne-Fleur R L van Hal,
Arnold J N Bittermann,
Colin R Butler,
Ilse Ceelie,
Daniela Cianci,
Caroline Gahm,
Julia E Hut,
Reema Nandi,
Lonneke M Staals,
Stefaan H A J Tytgat,
Maud Y A Lindeboom
Affiliations
René M H Wijnen
Department 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
Petra M A Lemmers
Department of Neonatology, Wilhelmina Children`s Hospital University Medical Center, Utrecht, The Netherlands
Bas Pullens
Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC - Sophia Children Hospital, Rotterdam, The Netherlands
Dhanya Mullassery
Department of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK
Paolo De Coppi
Department of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK
Peter M van de Ven
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
Jan F Svensson
Department of Paediatric Surgery, Karolinska University Hospital, Stockholm, Sweden
Koen F M Joosten
Department of Neonatal and Paediatric Intensive Care, Division of Paediatric Intensive Care, Erasmus MC - Sophia Children`s Hospital, Rotterdam, The Netherlands
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
Anne-Fleur R L van Hal
Department of Paediatric Surgery, Erasmus MC - Sophia Children`s Hospital, Rotterdam, The Netherlands
Arnold J N Bittermann
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
Colin R Butler
Department of Otorhinolaryngology, Great Ormond Street Hospital for Children, London, UK
Ilse Ceelie
Department of Anaesthesiology, Wilhelmina Children`s Hospital University Medical Center, Utrecht, The Netherlands
Daniela Cianci
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands
Caroline Gahm
Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska University Hospital, Stockholm, Sweden
Julia E Hut
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
Reema Nandi
Department of Anaesthesia, Great Ormond Street Hospital for Children, London, UK
Lonneke M Staals
Department of Anaesthesiology, Erasmus MC - Sophia Children`s Hospital, Rotterdam, The Netherlands
Stefaan H A J Tytgat
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
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
Introduction Tracheomalacia (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.
