Role of Proton Pump Inhibitors in Reducing Aspiration for Pediatric Laryngomalacia
Official title: Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
Run by Minia University · NCT07750379 · Data updated 2026-11-12
This study tests whether adding a proton pump inhibitor helps reduce swallowing problems and aspiration in children with laryngomalacia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 5 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT07750379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 months to 5 years with laryngomalacia and a history of choking or aspiration symptoms, without neurological impairment or other congenital anomalies.
✕Probably not a fit
Children with non-aspiration-related feeding issues or those with contraindications to PPI therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares standard care with and without a proton pump inhibitor in pediatric patients with laryngomalacia. Participants aged 6 months to 5 years with laryngomalacia and recurrent choking or aspiration symptoms are randomized to receive PPI therapy in addition to standard care or standard care alone. All participants receive vitamin D and feeding instructions, and undergo baseline and follow-up clinical and swallowing assessments to measure aspiration incidence and swallowing outcomes. The goal is to determine if PPI treatment can improve swallowing safety and reduce aspiration in this population.
Why it matters
Potential benefit: If successful, adding PPI therapy could reduce aspiration events and improve feeding safety in children with laryngomalacia.
How similar studies have gone: Evidence on PPI effectiveness for reducing aspiration in laryngomalacia is limited, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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faculty of Medicine, Minia University
Minya, Minya Governorate, Egypt Recruiting
Similar studies
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This study looks at how laryngomalacia affects the quality of life for children and sees if treatment, including surgery, can help them feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.