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Recruiting Not applicable

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

NCT07750379 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-04-28
Last updated
2026-08-06

Condition(s) studied

Laryngomalacia

Investigational drug(s) / intervention(s)

PPI →vitamin Dfeeding instruction

PPI: Proton pump inhibitor therapy administered according to the study protocol

vitamin D: Vitamin D supplementation administered according to the study protocol.

feeding instruction: Standard feeding instructions provided to caregivers according to the study protocol.

Study 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

Eligibility

Sex
ALL
Min age
6 Months
Max age
5 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of aspiration — 2months
    comparison of the incidence of aspiration between the PPI group and the standard group

Trial sites (1)

FacilityCityRegionStatus
faculty of Medicine, Minia University Minya Minya Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07750379 on ClinicalTrials.gov ↗ ← All trials in Egypt