Trial record 13 of 19 for:
Open Studies | "Cartilage Diseases"
Laryngomalacia Study
This study is not yet open for participant recruitment.
Verified January 2013 by Children's & Women's Health Centre of British Columbia
Sponsor:
Children's & Women's Health Centre of British Columbia
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: February 1, 2013
Last verified: January 2013
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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:
MedlinePlus related topics:
GERD
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 22 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782560
Contacts
| Contact: Neil K Chadha, MBChB(Hons)MPHeBSc(Hons)FRCS | 604-875-3730 | |
| Contact: Rachelle C Moshfeghi, BSc | 604-875-2345 ext 5189 | rachelle.darsantos@cw.bc.ca |
Locations
| Canada, British Columbia | |
| BC Children's Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada, V6H 3N1 | |
| Contact: Rachelle C Moshfeghi 604-875-2345 ext 5189 rachelle.darsantos@cw.bc.ca | |
| Contact: C | |
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: | February 1, 2013 |
| 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:
|
Cartilage Diseases Laryngomalacia Musculoskeletal Diseases Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Musculoskeletal Abnormalities Congenital Abnormalities Connective Tissue Diseases |
Omeprazole Proton Pump Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013