Back to resultsSystemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisolone and amoxicillin/clavulanate
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive sleep apnea syndrome (OSAS) in children
Eligibility Criteria
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.
Sites / Locations
- University of Chicago
Outcomes
Primary Outcome Measures
Sleep apnea questionnaire
Size of tonsils
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456339
Brief Title
Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Official Title
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Problems recruiting; patient relapse following treatment
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Obstructive sleep apnea syndrome (OSAS) in children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prednisolone and amoxicillin/clavulanate
Intervention Description
Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
Primary Outcome Measure Information:
Title
Sleep apnea questionnaire
Time Frame
1-2 weeks post treatment
Title
Size of tonsils
Time Frame
before and after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuad M Baroody, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
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Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
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