Prevention Recurrent Otitis Media in the Young Children

Otitis Media Clinical Trial

Official title:

Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00162994
• Other study ID #: K53715
• Status: Active, not recruiting
• Phase: N/A
• First received: September 10, 2005
• Last updated: December 20, 2005
• Start date: February 2002
• Est. completion date: August 2005

Study information

• Verified date: February 2002
• Source: Oulu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Months to 24 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Procedure:
• adenoidectomy and tymapanostomy

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- number of acute otitis media
Primary	- quality of life issues
Secondary	- time to first recurrence
Secondary	- speed of recovery of each otitis media
Secondary	- number of days of middle ear effusion
Secondary	- number of upper respiratory infections
Secondary	- prevention of otitis media caused by pnemococcus in carrier of pneumococcus