Prevention Recurrent Otitis Media in the Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.

Detailed Description

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Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.

In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.

Conditions

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Otitis Media

Keywords

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recurrent otitis media adenoidectomy tympanostomy young children prevention quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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adenoidectomy and tymapanostomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* at least 3 otitis media episodes during the last half year
* address near (\< 50 km) the university hospital of Oulu

Exclusion Criteria

* otitis media effusion lasting longer than two months without acute exacerbations
* prior adenoidectomy or tympanostomy
* head or neck malformation
* retarded child
* serious disease
* chemoprophylaxis for another disease

Minimum Eligible Age

10 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No