Evaluating Proton Pump Inhibitor Therapy to Reduce Aspiration in Children With Laryngomalacia Aged 6 Months to 5 Years

What this Trial Is About

Laryngomalacia is the most common congenital laryngeal anomaly in infants and is often linked to feeding difficulties and aspiration. This randomized controlled trial evaluates whether proton pump inhibitor PPI therapy can reduce the incidence of aspiration in children aged 6 months to 5 years with laryngomalacia. The study aims to provide evidence to improve management and reduce aspiration-related complications. Participants will be randomly assigned to one of two groups one receiving PPI therapy along with vitamin D supplementation and feeding instructions, and the other receiving vitamin D supplementation and feeding instructions only as standard care. Clinical and swallowing evaluations will be conducted at the start and during follow-up to compare aspiration rates and swallowing outcomes between the groups. During the study, children will undergo clinical assessments and swallowing tests at baseline and follow-up visits. Researchers will measure the incidence of aspiration over two months to determine the effect of adding PPI therapy. The study includes safety monitoring and lasts until the completion date, with participant involvement spanning the treatment and follow-up periods to assess outcomes.

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