A Phase 1 interventional study of Omeprazole and Placebo in Laryngomalacia, sponsored by Children's & Women's Health Centre of British Columbia. Withdrawn at 1 site in Canada. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2015-07-30.
Sponsored by Children's & Women's Health Centre of British Columbia · Phase 1, Interventional, and Treatment
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.
Children's & Women's Health Centre of British Columbia is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:Children cannot participate in this study if they have:
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
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
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.
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).
Time frame: Change from baseline and at end of study (baseline and 8 weeks)
Caring For a Child with Laryngomalacia Family Impact Questionnaire
Time frame: Change from baseline and at end of study (baseline and 8 weeks)
Revised Infant Gastro-Esophageal Reflux Questionnaire
Time frame: Change from baseline and at end of study (baseline and 8 weeks)
Reflux Finding Score
Time frame: Change from baseline and at end of study (baseline and 8 weeks)
End of treatment 24-hour double-probe pH monitoring
Time frame: Change from baseline and at end of study (baseline and 8 weeks)
Weight
Time frame: Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks)
This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Laryngomalacia
Children's & Women's Health Centre of British Columbia