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

NCT07750379 | Recruiting

• 1 other identifier: Approval No.1714/09/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Laryngomalacia

Keywords

laryngomalacia; aspiration; PPI; GERD; Pediatric

Outcome Measures

Primary Outcomes (1)

• Incidence of aspiration

  comparison of the incidence of aspiration between the PPI group and the standard group

  2months

Study Arms (2)

PPI group

EXPERIMENTAL

Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.

Drug: PPI; Dietary Supplement: vitamin D; Behavioral: feeding instruction

standard group

ACTIVE COMPARATOR

Participants receive vitamin D supplementation and feeding instructions only.

Dietary Supplement: vitamin D; Behavioral: feeding instruction

Interventions

PPI DRUG

Proton pump inhibitor therapy administered according to the study protocol

Also known as: Esomeprazole

PPI group

vitamin D DIETARY_SUPPLEMENT

Vitamin D supplementation administered according to the study protocol.

PPI group; standard group

feeding instruction BEHAVIORAL

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

PPI group; standard group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

faculty of Medicine, Minia University

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Laryngomalacia; Gastroesophageal Reflux

Interventions

Esomeprazole; Vitamin D

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, caregivers, investigators, and outcome assessors are aware of the assigned intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Participants will be randomly assigned in a parallel design to one of two groups. The intervention group will receive PPI therapy in addition to standard care (vitamin D supplementation and feeding instructions), while the control group will receive standard care alone. Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

EG (1)