Clinical trial NCT01782560: Laryngomalacia Study
Official title: Improving Care For Infants With Laryngomalacia: A Pilot Randomized Controlled Trial of Omeprazole Versus Placebo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Laryngomalacia
Keywords: Laryngomalacia
Acid-reflux
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Laryngomalacia Symptom Score
timeFrame: Change from baseline and at end of study (baseline and 8 weeks)
Secondary outcomes:
measure: Caring For a Child with Laryngomalacia Family Impact Questionnaire
timeFrame: Change from baseline and at end of study (baseline and 8 weeks)
measure: Revised Infant Gastro-Esophageal Reflux Questionnaire
timeFrame: Change from baseline and at end of study (baseline and 8 weeks)
measure: Reflux Finding Score
timeFrame: Change from baseline and at end of study (baseline and 8 weeks)
measure: End of treatment 24-hour double-probe pH monitoring
timeFrame: Change from baseline and at end of study (baseline and 8 weeks)
measure: Weight
timeFrame: Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: Provincial Health Services Authority
name: Neil K Chadha, MBChB(Hons)MPHeBSc(Hons)FRCS
role: PRINCIPAL_INVESTIGATOR
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