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NCT00456339 Clinical Trial

Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00456339
Other study ID # 001 (14397A)
Secondary ID
Status Terminated
Phase Phase 4
First received April 3, 2007
Last updated September 4, 2013
Start date July 2006
Est. completion date July 2007

Study information
Verified date September 2013
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 4
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Months to 12 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Prednisolone and amoxicillin/clavulanate
Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days

Locations
Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep apnea questionnaire 1-2 weeks post treatment No
Primary Size of tonsils before and after treatment No
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