Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

Overview

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.

Full Title of Study: “The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2007

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Sleep apnea questionnaire
    • Time Frame: 1-2 weeks post treatment
  • Size of tonsils
    • Time Frame: before and after treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fuad M Baroody, MD, Principal Investigator, University of Chicago

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