Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 3, 2007

Last Updated Date

May 27, 2008

Start Date ^†

July 2006

Current Primary Outcome Measures ^†

Sleep apnea questionnaire [ Time Frame: 1-2 weeks post treatment ] [ Designated as safety issue: No ]
Size of tonsils [ Time Frame: before and after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Sleep apnea questionnaire
Size of tonsils

Change History

Complete list of historical versions of study NCT00456339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

Official Title ^†

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

Brief 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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Obstructive Sleep Apnea Syndrome

Intervention ^†

Drug: Prednisolone and amoxicillin/clavulanate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456339

Responsible Party

Fuad M. Baroody, MD, University of Chicago

Secondary IDs ^††

Study Sponsor ^†

University of Chicago

Collaborators ^††

Investigators ^†

Principal Investigator:

Fuad M Baroody, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

May 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.