RecruitingNot Applicable

Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases

Egypt60 participantsStarted 2026-04-28

Plain-language summary

Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either a PPI treatment group or a control group. Clinical and swallowing assessments will be performed to compare aspiration incidence and swallowing outcomes between the two groups

Who can participate

Age range

6 Months – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms.
. Children aged from 6 months to 5 years.

Exclusion criteria

. Children with any neurological impairment.
. Children with other congenital anomalies.
. Children with other causes of respiratory distress

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of aspiration

Timeframe: 2months

Trial details

NCT IDNCT07750379

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Laryngomalacia trials