collapse of the windpipe Tracheomalacia
Conditions
Interventions
randomization between performing a PPT or no-PPT
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Patients with esophageal atresia type with a distal tracheoesophageal fistula (TEF), with tracheomalacia, written informed consent by both parent(s) or legal representative(s).
Exclusion criteria
Exclusion criteria: Patients with esophageal atresia without a distal TEF, premature neonates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The difference in the degree of tracheal collapse between the PPT and the no-PPT group measured in percentage of the tracheal diameter, during: - An intra-operative bronchoscopy after freeing the trachea and esophagus and, in case of PPT-group, the PPT, but before the surgical correction of EA, through the ventilation tube in the surgical theatre. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: The difference in the degree of tracheal collapse between the PPT and the no-PPT group in percentages as measured during: - a first postoperative bronchoscopy through the ventilation tube during routine extubation in the pediatric or neonatal intensive care unit - a second postoperative bronchoscopy that is conducted under general anesthesia in the surgical theatre after approximately 2-6 months. This bronchoscopy serves as a key secondary endpoint and aims to determine whether the effect of PPT is sustained and/or if the TM deteriorates beyond the first 2 months. | — |
Countries
Netherlands
Outcome results
None listed