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Tiny cameras may spare newborns breathing tubes during diagnosis

NCT ID NCT07687628

Disease control Sponsor: Papa Giovanni XXIII Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether a flexible video-endoscope, used while babies breathe on their own, can diagnose tracheoesophageal fistula (a birth defect where the windpipe and food pipe are connected) as accurately as the standard rigid scope that requires a breathing tube. About 60 newborns needing surgery for this condition will be examined with both methods. If the flexible camera works well, it could make diagnosis safer and less invasive for these fragile infants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
flexible video endoscopy device
What this could lead to
If flexible video-endoscopy works as well as rigid scopes, it could allow diagnosis without a breathing tube, reducing risks for fragile newborns.
What could go wrong
This is a small, single-center study comparing two techniques. Flexible scopes may not visualize the fistula as clearly, and sedation in spontaneously breathing babies carries its own risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive neonates undergoing surgical repair of esophageal atresia with or without tracheoesophageal fistula at a single tertiary pediatric center (ASST Papa Giovanni XXIII, Bergamo, Italy). The retrospective cohort includes patients treated from January 2013; the prospective cohort includes patients enrolled from October 2024 onward.

Ages

0 to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

esophageal atresia/tracheoesophageal fistula Tracheoesophageal Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal atresia with tracheo-esophageal fistula Tracheoesophageal fistula

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sc Ricerca Clinica, Sviluppo E Innovazione

    RECRUITING

    Bergamo, Italy, 24100, Italy

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