Prevention Recurrent Otitis Media in the Young Children

Not Applicable

• Conditions: Otitis Media

• Registration Number: NCT00162994
• Lead Sponsor: Oulu University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2002-02
• Study Start: 2002-02
• Study Completion: 2005-08
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-13
• Last Update Submitted: 2005-12-20
• Last Update Posted: 2005-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- number of acute otitis media
- quality of life issues

Secondary Outcome Measures

Name	Time	Method
- time to first recurrence
- speed of recovery of each otitis media
- number of days of middle ear effusion
- number of upper respiratory infections
- prevention of otitis media caused by pnemococcus in carrier of pneumococcus

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland