Camera-based Endoscopy to Manage Airway in Neonates with Tracheoesophageal Fistula
Official title: Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Run by Papa Giovanni XXIII Hospital · NCT07687628 · Data updated 2026-11-12
This observation compares rigid tracheoscopy with flexible tracheo-video-endoscopy in newborns needing pre-repair airway assessment for tracheoesophageal fistula.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 28 Days |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Papa Giovanni XXIII Hospital Academic / other |
| Locations | 1 site (Bergamo, Italy) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | January 31, 2029 |
| Study ends | January 31, 2031 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07687628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates with esophageal atresia with or without a tracheoesophageal fistula who underwent surgical repair at ASST Papa Giovanni XXIII in Bergamo since 2013 and whose guardians provided informed consent.
✕Probably not a fit
Patients unlikely to benefit are those not meeting inclusion criteria or whose condition precludes effective endoscopic assessment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates two preoperative airway assessment methods in neonates with tracheoesophageal fistula, with or without esophageal atresia. It compares rigid tracheoscopy performed under paralysis to flexible video-endoscopy that preserves spontaneous breathing, using new disposable miniaturized video endoscopes. The goal is to determine which approach provides better visualization and safer assessment prior to congenital repair, addressing airway management challenges. The study is ambispective, drawing on past cases and prospectively collected data at a single Italian center. Findings could inform preoperative airway strategies for these rare congenital conditions.
Why it matters
Potential benefit: If successful, the study could improve preoperative airway assessment and reduce perioperative airway complications for neonates with tracheoesophageal fistula.
How similar studies have gone: Previous work suggests that flexible video-endoscopy can improve airway visualization, but this exact comparative approach in neonates is limited and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Sc Ricerca Clinica, Sviluppo E Innovazione
Bergamo, Italy, Italy Recruiting
Study contacts
- Study coordinator: Stefano Mariconti, MD
- Email: smariconti@asst-pg23.it
- Phone: +39 035.267.5150/49
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.