Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrom... | NCT00456339

Studies
Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

NCT00456339

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Sep 5, 2013Estimated

Enrollment

4Actual

Phase

Phase 4

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Prednisolone and amoxicillin/clavulanate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Problems recruiting; patient relapse following treatment

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Apr 3, 2007

First Submission Date that Met QC Criteria

Apr 3, 2007

First Posted Date

Apr 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone and amoxicillin/clavulanate	Drug	Prednisolone 1mg/kg QD for 5 days Amoxicillin/clavulanate 45mg/Kg/d divided BID for 10 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep apnea questionnaire		1-2 weeks post treatment
Size of tonsils		before and after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fuad M Baroody, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone
D000658	Amoxicillin
D019818	Clavulanic Acid

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided