Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea Syndrome
Intervention: Prednisolone and amoxicillin/clavulanate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Fuad M Baroody, MD, Principal Investigator, Affiliation: University of Chicago
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.
Clinical Details
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
Primary outcome: Sleep apnea questionnaireSize of tonsils
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.
Eligibility
Minimum age: 18 Months.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: July 2006
Last updated: September 4, 2013
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