Study: NCT06335862

Intervention type: OTHER
Group type: OTHER
Intervention: Randomisation between the PPT- and no-PPT-group
Description: Randomisation is performed between two possible treatment options for tracheomalacia in OA patients; the PPT or the wait-and-see policy (no-PPT).

Intervention type: OTHER
Group type: OTHER
Intervention: Randomisation between the PPT- and no-PPT-group
Description: Randomisation is performed between two possible treatment options for tracheomalacia in OA patients; the PPT or the wait-and-see policy (no-PPT).

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Primary Posterior Tracheopexy
Description: The PPT involves fixating the posterior membrane of the trachea to the spinal ligament with sutures, to prevent the trachea from collapsing.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Preoperative tracheobronchoscopy
Description: Prior to OA correction, a flexible and a rigid tracheobronchoscopy will be performed, in addition to a flexible tracheobronchoscopy through the endotracheal tube. Preoperative evaluation of TM through a tracheobronchoscopy is part of standard care for all participating centres.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Preoperative tracheobronchoscopy
Description: Prior to OA correction, a flexible and a rigid tracheobronchoscopy will be performed, in addition to a flexible tracheobronchoscopy through the endotracheal tube. Preoperative evaluation of TM through a tracheobronchoscopy is part of standard care for all participating centres.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Intraoperative tracheobronchoscopy
Description: After the PPT is performed, or in case of the no-PPT group at the stage of the surgery when the PPT would usually be performed, a flexible tracheobronchoscopy through the endotracheal tube is carried out. This tracheobronchoscopy is routine care for all patients undergoing a PPT, and is additional for patients in the no-PPT-group.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Intraoperative tracheobronchoscopy
Description: After the PPT is performed, or in case of the no-PPT group at the stage of the surgery when the PPT would usually be performed, a flexible tracheobronchoscopy through the endotracheal tube is carried out. This tracheobronchoscopy is routine care for all patients undergoing a PPT, and is additional for patients in the no-PPT-group.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Postoperative tracheobronchoscopy through the endotracheal tube during extubation
Description: A postoperative flexible tracheobronchoscopy is performed in the neonatal or pediatric intensive care unit (ICU), through the endotracheal tube during extubation. This procedure is a study intervention.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Postoperative tracheobronchoscopy through the endotracheal tube during extubation
Description: A postoperative flexible tracheobronchoscopy is performed in the neonatal or pediatric intensive care unit (ICU), through the endotracheal tube during extubation. This procedure is a study intervention.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Postoperative tracheobronchoscopy after 2-6 months
Description: Two to six months after OA correction, a follow-up flexible and a rigid tracheobronchoscopy will be performed, under general anesthesia in the surgical theatre. This postoperative evaluation of TM through a tracheobronchoscopy is part of standard care for the Karolinska University Hospital and Great Ormond Street Hospital. At the University Medical Centre Utrecht and Erasmus Medical Centre Rotterdam, this tracheobronchoscopy is performed on indication in approximately half of patients. For the other half of patients, this is a study intervention.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Postoperative tracheobronchoscopy after 2-6 months
Description: Two to six months after OA correction, a follow-up flexible and a rigid tracheobronchoscopy will be performed, under general anesthesia in the surgical theatre. This postoperative evaluation of TM through a tracheobronchoscopy is part of standard care for the Karolinska University Hospital and Great Ormond Street Hospital. At the University Medical Centre Utrecht and Erasmus Medical Centre Rotterdam, this tracheobronchoscopy is performed on indication in approximately half of patients. For the other half of patients, this is a study intervention.