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Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

This study has been terminated.
(Problems recruiting; patient relapse following treatment)
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00456339
First received: April 3, 2007
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

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 ]

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)
Intervention Details:
    Drug: Prednisolone and amoxicillin/clavulanate
    Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days
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.

  Eligibility

Ages Eligible for Study:   18 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456339

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Fuad M Baroody, MD University of Chicago
  More Information

No publications provided

Responsible Party: Fuad M. Baroody, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00456339     History of Changes
Other Study ID Numbers: 001 (14397A)
Study First Received: April 3, 2007
Last Updated: May 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Obstructive sleep apnea syndrome (OSAS) in children

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Amoxicillin
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
 Clavulanic Acid
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013