NCT00456339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

April 3, 2007

Last Update Submit

September 4, 2013

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive sleep apnea syndrome (OSAS) in children

Outcome Measures

Primary Outcomes (2)

  • Sleep apnea questionnaire

    1-2 weeks post treatment

  • Size of tonsils

    before and after treatment

Interventions

Prednisolone and amoxicillin/clavulanateDRUG

Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Polysomnogram results showing mild obstructive sleep apnea.

You may not qualify if:

  • Significant medical problems
  • Chronic medication intake (except bronchodilators and inhaled steroids)
  • Allergy to penicillin or its derivatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

PrednisoloneAmoxicillinClavulanic Acid

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic Acids

Study Officials

  • Fuad M Baroody, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)