Clinical Trial: Laryngomalacia Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Children's & Women's Health Centre of British Columbia

Current Primary Outcome: Laryngomalacia Symptom Score [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]


Original Secondary Outcome: Same as current

Information By: Children's & Women's Health Centre of British Columbia

Dates:
Date Received: January 17, 2013
Date Started: February 2013
Date Completion:
Last Updated: July 28, 2015
Last Verified: July 2015