Laryngomalacia Study

Study Overview
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Brief Summary
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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.

Official Title
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Improving Care For Infants With Laryngomalacia: A Pilot Randomized Controlled Trial of Omeprazole Versus Placebo

Conditions
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Laryngomalacia

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Two different placebo formulations will be created which will designed to be identical in appearance, taste, and consistency to the two study medications. | Drug: Placebo<br> <br> |
| Active Comparator: Omeprazole<br>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. 2 mg/kg/day omeprazole. | Drug: Omeprazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline and at end of study (baseline and 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caring For a Child with Laryngomalacia Family Impact Questionnaire |  | Change from baseline and at end of study (baseline and 8 weeks) | 
| Revised Infant Gastro-Esophageal Reflux Questionnaire |  | Change from baseline and at end of study (baseline and 8 weeks) | 
| Reflux Finding Score |  | Change from baseline and at end of study (baseline and 8 weeks) | 
| End of treatment 24-hour double-probe pH monitoring |  | Change from baseline and at end of study (baseline and 8 weeks) | 
| Weight |  | Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngomalacia, Acid-reflux