Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Information source: University of Chicago
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea Syndrome
Intervention: Prednisolone and amoxicillin/clavulanate (Drug)
Phase: Phase 4
Sponsored by: University of Chicago
Official(s) and/or principal investigator(s):
Fuad M Baroody, MD, Principal Investigator, Affiliation: University of Chicago
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.
Official title: The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sleep apnea questionnaire
Size of tonsils
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.
Minimum age: 18 Months.
Maximum age: 12 Years.
- Polysomnogram results showing mild obstructive sleep apnea.
- Significant medical problems
- Chronic medication intake (except bronchodilators and inhaled steroids)
- Allergy to penicillin or its derivatives.
Locations and Contacts
University of Chicago, Chicago, Illinois 60637, United States
Starting date: July 2006
Last updated: September 4, 2013