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Clinical Trials in Italy / NCT07687628
Recruiting Observational

Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula

NCT07687628 · tracked via the Priya Life Science Italy tracker
Sponsor
Papa Giovanni XXIII Hospital
Phase
Observational
Started
2024-10-01
Last updated
2026-07-07

Condition(s) studied

Tracheoesophageal FistulaEsophageal Atresia With Tracheo-esophageal Fistula

Investigational drug(s) / intervention(s)

tracheoscopy performed with rigid optical tracheoscopyflexible video endoscopy of trachea

tracheoscopy performed with rigid optical tracheoscopy: Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation

flexible video endoscopy of trachea: Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates

Study summary

The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.

Eligibility

Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
No
Inclusion Criteria: * Neonates who have undergone surgical repair of esophageal atresia with or without tracheoesophageal fistula at ASST Papa Giovanni XXIII, Bergamo, from 1 January 2013 onwards * Written informed consent signed by both parents or legal guardian Exclusion Criteria: * Refusal or inability to obtain informed consent from parents or legal guardian

Primary outcome measure(s)

  • Diagnostic success rate of preoperative tracheoscopy — Intraoperative (at the time of the preoperative tracheoscopy procedure)
    Percentage of procedures in which the technique allowed correct visualization of the tracheoesophageal fistula, including identification of secondary fistulas, out of total procedures performed with each method (rigid vs flexible bronchoscopy)

Trial sites (1)

FacilityCityRegionStatus
Sc Ricerca Clinica, Sviluppo E Innovazione Bergamo Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07687628 on ClinicalTrials.gov ↗ ← All trials in Italy