The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS...
Date First Received: April 3, 2007
Last Updated: May 27, 2008
Verified by: University of Chicago, May 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2006
Overall Status: Terminated
Estimated Enrollment: 4
Brief Summary
Official Title: “The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Study Primary Completion Date: July 2007
Detailed Clinical Trial Description
We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.
Intervention(s) in this Clinical Trial
- Drug: Prednisolone and amoxicillin/clavulanate
- Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
Outcome Measures for this Clinical Trial
Primary Measures
- Sleep apnea questionnaire
- Time Frame: 1-2 weeks post treatment
Safety Issue?: No
- Time Frame: 1-2 weeks post treatment
- Size of tonsils
- Time Frame: before and after treatment
Safety Issue?: No
- Time Frame: before and after treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Polysomnogram results showing mild obstructive sleep apnea.
Exclusion Criteria:
- Significant medical problems
- Chronic medication intake (except bronchodilators and inhaled steroids)
- Allergy to penicillin or its derivatives.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Months
Maximum Age for this Clinical Trial: 12 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Chicago
Overall Clinical Trial Officials and Contacts
Fuad M Baroody, MD Principal Investigator University of Chicago
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00456339
Study ID Number: 001 (14397A)
ClinicalTrials.gov Identifier: NCT00456339
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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