Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456339
Status:
TERMINATED
Last Update Posted:
2013-09-05
First Post:
2007-04-03
Brief Title:
Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Problems recruiting patient relapse following treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 amoxicillinclavulanate 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None