Laryngomalacia
Conditions
Keywords
laryngomalacia, aspiration, PPI, GERD, Pediatric
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.
Interventions
DRUGPPI
Proton pump inhibitor therapy administered according to the study protocol
DIETARY_SUPPLEMENTvitamin D
Vitamin D supplementation administered according to the study protocol.
BEHAVIORALfeeding instruction
Standard feeding instructions provided to caregivers according to the study protocol.
Sponsors
Minia University
Study design
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
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of aspiration | 2months | comparison of the incidence of aspiration between the PPI group and the standard group |
Countries
Egypt
Outcome results
None listed