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Can a common acid reflux drug protect Children's airways?

NCT ID NCT07750379

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether giving a proton pump inhibitor (PPI) to children with laryngomalacia—a common birth defect of the voice box—can reduce the chance of food or liquid entering the airway (aspiration). Children aged 6 months to 5 years with recurrent choking or aspiration symptoms will be randomly assigned to receive PPI therapy or standard care. Researchers will compare aspiration rates and swallowing outcomes between the two groups to see if the medication helps.

What this could mean

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

Active substance
Proton pump inhibitor (esomeprazole) therapy, vitamin D supplementation, and standard feeding instructions
What this could lead to
If effective, this could establish PPI therapy as a standard way to lower aspiration risk and improve swallowing outcomes in children with laryngomalacia.
What could go wrong
The trial is small (60 children) and early, so results may not apply broadly. PPIs carry potential side effects, and the study's findings may not confirm a clear benefit.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Apr 2026

Expected to finish

Dec 2026

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.

Ages

6 months to 5 years

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: 1. Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms. 2. Children aged from 6 months to 5 years. Exclusion Criteria: 1. Children with any neurological impairment. 2. Children with other congenital anomalies. 3. Children with other causes of respiratory distress

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Conditions

The condition(s) this trial relates to.

congenital laryngomalacia gastroesophageal reflux disease

As listed by the trial registrant

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

Laryngomalacia

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

  • faculty of Medicine, Minia University

    RECRUITING

    Minya, Minya Governorate, Egypt