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

NCT07687628 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-07-07

No results posted yet for this 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.

Conditions

  • Tracheoesophageal Fistula
  • Esophageal Atresia With Tracheo-esophageal Fistula

Interventions

PROCEDURE

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

DEVICE

flexible video endoscopy of trachea

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

Sponsors & Collaborators

  • Papa Giovanni XXIII Hospital

    lead OTHER

Principal Investigators

  • Ezio Bonanomi, MD · A.O. Ospedale Papa Giovanni XXIII

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2029-01-31
Completion
2031-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687628 on ClinicalTrials.gov