drugset / Trial / NCT01782560

Laryngomalacia Study

NCT01782560

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Noisy breathing is commonly caused by a floppy voicebox which is a condition called laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have suggested that it could be due to acid escaping from the stomach and spreading up the swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is therefore one of the most common reasons for infants to see Otolaryngologists at BC Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms including squeaky breathing, choking, difficulty feeding, failure to gain weight, and episodes of turning blue (due to lack of oxygen). At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia medication to reduce the amount of acid they make in their stomachs, in the hope that this will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed whether anti-reflux medication will benefit these children any more than doing nothing at all.

Timeline

Start
2013-02
Primary completion
2015-07
Completion
2015-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omeprazole Other / unclassified 2 mg/kg

Indications