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Laryngomalacia Study

Primary Purpose

Laryngomalacia

Status

Withdrawn

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Omeprazole

Placebo

About this trial

This is an interventional treatment trial for Laryngomalacia focused on measuring Laryngomalacia, Acid-reflux

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

BC Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Omeprazole

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Caring For a Child with Laryngomalacia Family Impact Questionnaire

Revised Infant Gastro-Esophageal Reflux Questionnaire

Reflux Finding Score

End of treatment 24-hour double-probe pH monitoring

Weight

Full Information

NCT ID

NCT01782560

First Posted

January 17, 2013

Last Updated

July 28, 2015

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01782560

Brief Title

Laryngomalacia Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit a sufficient amount of subjects

Study Start Date

February 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngomalacia

Keywords

Laryngomalacia, Acid-reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Omeprazole

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Intervention 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. 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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Laryngomalacia Symptom Score

Description

Time Frame