NCT00456339

Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Prednisolone and amoxicillin/clavulanate	Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-04-04
• Last updated: 2013-09-05

Locations

1 site across 1 country: United States