An interventional study of PPI and vitamin D in Laryngomalacia, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions.
Drug: PPI · Dietary Supplement: vitamin D · Behavioral: feeding instruction
Participants receive vitamin D supplementation and feeding instructions only.
Dietary Supplement: vitamin D · Behavioral: feeding instruction
Proton pump inhibitor therapy administered according to the study protocol
Also known as: Esomeprazole
Vitamin D supplementation administered according to the study protocol.
Standard feeding instructions provided to caregivers according to the study protocol.
Incidence of aspiration
comparison of the incidence of aspiration between the PPI group and the standard group
Time frame: 2months
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
Of 192 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's planned 8 months is below that.
Counting every sponsor, half of 225 studies reached it within 32 months; a quarter within 12 and three quarters within 68.
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Studies of the drug tested here: Proton pump inhibitors (PPIs)