Laryngomalacia Study

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

Status and phase: Withdrawn; Phase 1

Conditions: Laryngomalacia

Treatments: Drug: Placebo; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01782560

H12-03495

Details and patient eligibility

About

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.

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two different placebo formulations will be created which will designed to be identical in appearance, taste, and consistency to the two study medications.

Treatment:

Drug: Placebo

Omeprazole

Active Comparator group

Description:

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.

Treatment:

Drug: Omeprazole