Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Phase 4
Terminated
- Conditions
- Obstructive Sleep Apnea Syndrome
- Registration Number
- NCT00456339
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sleep apnea questionnaire 1-2 weeks post treatment Size of tonsils before and after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States