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Can we predict breathing problems in cleft surgery? new study aims to find out

NCT ID NCT07651904

Knowledge-focused Sponsor: Marmara University Pendik Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 150 infants and toddlers having cleft lip or palate repair to understand how often breathing complications occur and what factors increase risk. Researchers will use standard airway scoring tools to see if they can predict problems like laryngospasm or low oxygen levels. No new treatments are tested; the goal is to gather information that could improve safety for future surgeries.

What this could mean

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

What this could lead to
If successful, this study could help doctors predict which children are at higher risk for breathing problems during cleft surgery, leading to better safety measures.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change care. Results may not apply to all hospitals or children.

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 150 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

Infants and toddlers aged 0-3 years scheduled for elective cleft lip and/or palate repair under general anesthesia . No randomization is performed; all management follows routine institutional anesthesia practice.

Ages

0 to 3 years

Sex

Anyone

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: * Age 0-3 years (infants and toddlers) * Scheduled for elective cleft lip and/or palate repair surgery * General anesthesia planned * Written parental/guardian informed consent obtained Exclusion Criteria: * Pre-existing respiratory failure or active tracheostomy * Emergency surgical procedures * Inability to obtain parental/guardian consent

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Conditions

The condition(s) this trial relates to.

Airway Obstruction bronchial disorder Bronchial Spasm cleft lip cleft palate Laryngismus laryngospasm, severe neonatal episodic Micrognathism Postoperative Complications

As listed by the trial registrant

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

Airway obstruction Bronchospasm Cleft lip Cleft palate Difficult intubation Laryngospasm Postoperative complications

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.