Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence of aspiration
Study Overview
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
Detailed Description
Laryngomalacia is the most common congenital laryngeal anomaly in infants and is frequently associated with feeding difficulties and aspiration. Gastroesophageal reflux has been suggested to contribute to symptom severity and aspiration in these patients. Although proton pump inhibitors (PPIs) are commonly prescribed, evidence regarding their effectiveness in reducing aspiration is still limited.
This randomized controlled trial aims to evaluate the role of PPI therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either an intervention group receiving PPI therapy in addition to standard care or a control group receiving standard care alone. Standard care will include vitamin D supplementation and feeding instructions for all participants. Clinical evaluation and swallowing assessment will be performed at baseline and during follow-up. The incidence of aspiration and swallowing outcomes will be compared between the two groups to determine the effectiveness of adding PPI therapy to standard management. The results of this study may provide evidence to optimize the management of pediatric laryngomalacia and reduce aspiration-related complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This is an open-label study. Participants, caregivers, investigators, and outcome assessors are aware of the assigned intervention
Eligibility Criteria
- Ages
- 6 Months to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
Intervention: PPI (Drug)
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
Intervention: feeding instruction (Behavioral)
standard group
Participants receive vitamin D supplementation and feeding instructions only.
Intervention: feeding instruction (Behavioral)
PPI group
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
Intervention: vitamin D (Dietary Supplement)
standard group
Participants receive vitamin D supplementation and feeding instructions only.
Intervention: vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
Incidence of aspiration
Time Frame: 2months
comparison of the incidence of aspiration between the PPI group and the standard group
Secondary Outcomes
No secondary outcomes reported
Investigators
Al shimaa Abd el monem
Assistant lecturer
Minia University