Laryngomalacia Study

This study has been withdrawn prior to enrollment.
(Unable to recruit a sufficient amount of subjects)
Sponsor:
Information provided by (Responsible Party):
Neil Chadha, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01782560
First received: January 17, 2013
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Laryngomalacia
Drug: Omeprazole
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Care For Infants With Laryngomalacia: A Pilot Randomized Controlled Trial of Omeprazole Versus Placebo

Resource links provided by NLM:


Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Laryngomalacia Symptom Score [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ] [ Designated as safety issue: No ]
  • Revised Infant Gastro-Esophageal Reflux Questionnaire [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ] [ Designated as safety issue: No ]
  • Reflux Finding Score [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ] [ Designated as safety issue: No ]
  • End of treatment 24-hour double-probe pH monitoring [ Time Frame: Change from baseline and at end of study (baseline and 8 weeks) ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782560

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Investigators
Principal Investigator: Neil K Chadha, MBChB(Hons)MPHeBSc(Hons)FRCS Provincial Health Services Authority
  More Information

Publications:

Responsible Party: Neil Chadha, Clinical Assistant Professor, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01782560     History of Changes
Other Study ID Numbers: H12-03495
Study First Received: January 17, 2013
Last Updated: July 28, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's & Women's Health Centre of British Columbia:
Laryngomalacia
Acid-reflux

Additional relevant MeSH terms:
Laryngomalacia
Cartilage Diseases
Congenital Abnormalities
Connective Tissue Diseases
Laryngeal Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015