Laryngomalacia Study

Children's & Women's Health Centre of British Columbia

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Laryngomalacia

Interventions

OmeprazoleDRUG

Omeprazole (a proton-pump inhibitor) is the most common treatment given to infants with laryngomalacia, in the hope that this will reduce their symptoms. Although this is an effective anti-reflux medication in this population, its use is off-label, and like any medication has potential risks, particularly in very young children. Side effects that have been described include abdominal pain, diarrhea, constipation, and cough. Although omeprazole is usually a safe medication, we do not currently know if it provides any benefit in laryngomalacia.

PlaceboDRUG

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * children less than 1 years old * children determined that they have laryngomalacia at the Pediatric Otolaryngology clinic at BC Children's Hospital. Exclusion Criteria:Children cannot participate in this study if they have: * those already on anti-reflux medicine and considered medically unsafe to go through the washout period; * allergy to the trial medications; * nasogastric or permanent feeding tube; * other laryngeal abnormalities.

Locations (1)

BC Children's Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Laryngomalacia Symptom Score

This score is a disease-specific quality of life measure for laryngomalacia. Each of the symptoms that can occur in laryngomalacia are scored as present (1) or absent (0) as follows - inspiratory stridor, suprasternal retraction, substernal retraction, feeding difficulty, choking, post-feeding vomit, failure to thrive (i.e. poor weight gain with deviation from the normal growth curve), and cyanosis. Therefore for each patient, a total symptom score is calculated (8 = all symptoms, 0 = no symptoms).