{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T03:56:23Z","timestamp":1783396583846,"version":"3.54.6"},"reference-count":31,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T00:00:00Z","timestamp":1733961600000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"For Wis(h)dom Foundation","award":["WF\/2022\/1310"],"award-info":[{"award-number":["WF\/2022\/1310"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,10,14]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>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\u2014or prevent\u2014tracheal 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06335862\">NCT06335862<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-087272","type":"journal-article","created":{"date-parts":[[2024,12,12]],"date-time":"2024-12-12T23:18:02Z","timestamp":1734045482000},"page":"e087272","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["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)"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct06335862","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2483-8719","authenticated-orcid":false,"given":"Marit J B","family":"van Stigt","sequence":"first","affiliation":[{"name":"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"},{"name":"Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Fleur R L","family":"van Hal","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnold J N","family":"Bittermann","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin R","family":"Butler","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Great Ormond Street Hospital for Children, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilse","family":"Ceelie","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Cianci","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"de Coppi","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Gahm","sequence":"additional","affiliation":[{"name":"Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska University Hospital, Stockholm, Sweden"},{"name":"Department of Head Neck, Lung and Skin Cancer, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia E","family":"Hut","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koen F M","family":"Joosten","sequence":"additional","affiliation":[{"name":"Department of Neonatal and Paediatric Intensive Care, Division of Paediatric Intensive Care, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra M A","family":"Lemmers","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhanya","family":"Mullassery","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Great Ormond Street Hospital for Children, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reema","family":"Nandi","sequence":"additional","affiliation":[{"name":"Department of Anaesthesia, Great Ormond Street Hospital for Children, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bas","family":"Pullens","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC - Sophia Children Hospital, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lonneke M","family":"Staals","sequence":"additional","affiliation":[{"name":"Department of Anaesthesiology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan F","family":"Svensson","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefaan H A J","family":"Tytgat","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter M","family":"van de Ven","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ren\u00e9 M H","family":"Wijnen","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Erasmus MC - Sophia Children's Hospital, Rotterdam, The 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