Laryngomalacia Study

July 28, 2015 updated by: Neil Chadha, Children's & Women's Health Centre of British Columbia

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
Active Comparator: 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. 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Caring For a Child with Laryngomalacia Family Impact Questionnaire
Time Frame: Change from baseline and at end of study (baseline and 8 weeks)
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)
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)
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)
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)
Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Neil K Chadha, MBChB(Hons)MPHeBSc(Hons)FRCS, Provincial Health Services Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-03495

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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