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| Sponsored by: |
University of Chicago |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00456339 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea Syndrome |
Drug: Prednisolone and amoxicillin/clavulanate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children |
| Enrollment: | 4 |
| Study Start Date: | July 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Fuad M Baroody, MD | University of Chicago |
More Information
| Responsible Party: | University of Chicago ( Fuad M. Baroody, MD ) |
| Study ID Numbers: | 001 (14397A) |
| Study First Received: | April 3, 2007 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00456339 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obstructive sleep apnea syndrome (OSAS) in children |
|
Anti-Inflammatory Agents Anti-Infective Agents Methylprednisolone Hormone Antagonists Sleep Apnea, Obstructive Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Clavulanic Acids Sleep Disorders Prednisolone acetate Neuroprotective Agents Hormones Sleep Disorders, Intrinsic Anti-Bacterial Agents Signs and Symptoms |
Respiratory Tract Diseases Clavulanic Acid Signs and Symptoms, Respiratory Methylprednisolone Hemisuccinate Amoxicillin Sleep Apnea Syndromes Antineoplastic Agents, Hormonal Apnea Respiration Disorders Dyssomnias Methylprednisolone acetate Amoxicillin-Potassium Clavulanate Combination Glucocorticoids Prednisolone Peripheral Nervous System Agents |
|
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Sleep Apnea, Obstructive Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Sleep Disorders Clavulanic Acids Prednisolone acetate Neuroprotective Agents Hormones Sleep Disorders, Intrinsic |
Signs and Symptoms Anti-Bacterial Agents Pathologic Processes Respiratory Tract Diseases Therapeutic Uses Syndrome Clavulanic Acid Signs and Symptoms, Respiratory Methylprednisolone Hemisuccinate Sleep Apnea Syndromes Amoxicillin Disease Antineoplastic Agents, Hormonal Apnea Nervous System Diseases |
