This trial is active, not recruiting.

Condition otitis media
Treatment adenoidectomy and tymapanostomy
Sponsor Oulu University Hospital
Start date February 2002
End date August 2005
Trial size 300 participants
Trial identifier NCT00162994, K53715


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

- number of acute otitis media
time frame:
- quality of life issues
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 10 months up to 24 months old.

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

Additional Information

Official title Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Principal investigator Olli-Pekka Alho, professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Oulu University Hospital.