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Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

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The University of Chicago

Status and phase

Terminated
Phase 4

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Drug: Prednisolone and amoxicillin/clavulanate

Study type

Interventional

Funder types

Other

Identifiers

NCT00456339
001 (14397A)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 months to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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