protocolSection identificationModule nctId: NCT06335862, orgStudyIdInfo id: NL.84862.041.23, briefTitle: Primary Posterior Tracheopexy Prevents Tracheal Collapse, acronym: PORTRAIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: For Wis(h)dom Foundation, collaborators name: Erasmus Medical Center, collaborators name: Great Ormond Street Hospital for Children NHS Foundation Trust, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT).Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed 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.Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial., conditionsModule conditions: Oesophageal Atresia With Tracheo-Oesophageal Fistula, conditions: Tracheomalacia, conditions: Oesophageal Atresia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized 1:1 into either the intervention group (PPT-group) or the wait-and-see group (no-PPT). Since the sutures of the PPT remain in place (in the PPT-group), the participants are allocated to one arm for the duration of the study. After the PPT was or was not performed, the participants will follow the same follow-up schedule., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: All participants, parents/caregivers, investigators and treating healthcare personnel, except for the surgical team performing the OA correction, will be blinded to which study arm the participant is assigned. None of the data gathered is affected by the unblinded surgical team since the primary and key secondary outcome measures are evaluated based on pseudonymised video footage. Furthermore, this video footage is assessed by otolaryngologists who are blinded to the patient and study arm. Moreover, the follow-up and documentation of the secondary endpoints are typically performed by the paediatrician and speech- and language therapists (not the paediatric surgeon or otolaryngologist)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Randomisation between the PPT- and no-PPT-group, interventions name: Primary Posterior Tracheopexy, interventions name: Preoperative tracheobronchoscopy, interventions name: Intraoperative tracheobronchoscopy, interventions name: Postoperative tracheobronchoscopy through the endotracheal tube during extubation, interventions name: Postoperative tracheobronchoscopy after 2-6 months, outcomesModule primaryOutcomes measure: Difference in degree of TM between the PPT-group and no-PPT-group during intraoperative tracheobronchoscopy, secondaryOutcomes measure: Key secondary outcome: Difference in degree of TM between the PPT-group and no-PPT-group during postoperative tracheobronchoscopy, secondaryOutcomes measure: Difference in symptoms between the PPT-group and no-PPT-group, secondaryOutcomes measure: Degree of preoperative TM compared to postoperative TM, eligibilityModule sex: ALL, minimumAge: 34 Weeks, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False