Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Study Overview
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Brief Summary
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This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.

Official Title
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The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Conditions
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Dysphonia

Intervention / Treatment
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* Drug: Lansoprazole
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children with a diagnosis of dysphonia age 3-18 years. Dysphonia must be present for at least one month duration. May have vocal cord nodules present. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel). Caregiver must be able to read, write, and understand English. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study. Exclusion Criteria: Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy. Dysphonia must not be due to an acute upper respiratory infection. Must not have been treated with proton pump inhibitor medication in the past 12 months. Inability of child to cooperate with recording of voice for analysis. Inability of caregiver to read, write, and understand English. Mental retardation, cognitive impairment, or developmental delay. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lansoprazole and dietary control<br>Lansoprazole and dietary control | Drug: Lansoprazole<br>* Lansoprazole 30 mg taken by mouth daily for 3 months<br>* Other names: Prevacid;|
| Placebo Comparator: Placebo and dietary control<br>Dietary control and placebo | Other: Placebo<br>* placebo taken by mouth daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Condition Over Treatment Period | Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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horseness