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

ConditionLaryngomalacia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-5

SponsorMinia University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Children with any neurological impairment.

Children with other congenital anomalies.

Children with other causes of respiratory distress

Trial design

Design model

Parallel

Treatments tested in this trial

PPI
Drug
Proton pump inhibitor therapy administered according to the study protocol
vitamin D
Dietary supplement
Vitamin D supplementation administered according to the study protocol.
feeding instruction
Behavioral
Standard feeding instructions provided to caregivers according to the study protocol.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: PPI groupExperimental treatment 3 interventions

Group B: standard groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Incidence of aspiration

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

Time frame

2months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Source ClinicalTrials.gov

Apply now