Primary pOsterioR TRacheopexy prevents collapse of the trachea in newborns with esophageal AtresIa and Tracheomalacia

Conditions: collapse of the windpipe
Tracheomalacia
10018018
10018008
10010613

Registration Number: NL-OMON56519

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

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

Patients with esophageal atresia without a distal TEF, premature neonates <34
weeks, endotracheal tube size < 3.0, cormack score 3 or 4 (as scored by either
the otolaryngologist, anesthesiologist, or neonatal/pediatric intensive care
specialist), patients with a cyanotic cor vitium.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>The difference in the degree of tracheal collapse between the PPT and the<br /><br>no-PPT group measured in percentage of the tracheal diameter, during:<br /><br>- An intra-operative bronchoscopy after freeing the trachea and esophagus and,<br /><br>in case of PPT-group, the PPT, but before the surgical correction of EA,<br /><br>through the ventilation tube in the surgical theatre.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoints:<br /><br>The difference in the degree of tracheal collapse between the PPT and the<br /><br>no-PPT group in percentages as measured during:<br /><br>- a first postoperative bronchoscopy through the ventilation tube during<br /><br>routine extubation in the pediatric or neonatal intensive care unit<br /><br>- a second postoperative bronchoscopy that is conducted under general<br /><br>anesthesia in the surgical theatre after approximately 2-6 months. This<br /><br>bronchoscopy serves as a key secondary endpoint and aims to determine whether<br /><br>the effect of PPT is sustained and/or if the TM deteriorates beyond the first<br /><br>2 months.</p><br>