Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

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

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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome:

Sleep apnea questionnaire

Size 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.

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.

University of Chicago, Chicago, Illinois 60637, United States

Starting date: July 2006
Ending date: July 2007
Last updated: May 27, 2008