RecruitingNCT07687628
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Sponsor
Papa Giovanni XXIII Hospital
Enrollment
60 participants
Start Date
Oct 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 0 DaysMax Age: 28 Days
Inclusion Criteria2
- 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 Criteria1
- Refusal or inability to obtain informed consent from parents or legal guardian
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
PROCEDUREtracheoscopy 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
DEVICEflexible video endoscopy of trachea
Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07687628