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| Sponsored by: |
Oulu University Hospital |
|---|---|
| Information provided by: | Oulu University Hospital |
| ClinicalTrials.gov Identifier: | NCT00162994 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Otitis Media |
Procedure: adenoidectomy and tymapanostomy |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children |
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2002 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 10 Months to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Finland | |
| Oulu University Hospital | |
| Oulu, Finland | |
| Study Director: | Petri Koivunen, PhD | Dept of Otolaryngology, University of Oulu, Finland |
| Principal Investigator: | Olli-Pekka Alho, professor | Dept of Otolaryngology, University of Oulu, Finland |
| Study Director: | Matti Uhari, professor | Dept of Pediatrics, University of Oulu, Finland |
| Principal Investigator: | Tiia Kujala, MD | Dept of Otolaryngology, University of Oulu, Finland |
| Study Director: | Jukka Luotonen, PhD | Dept of Otolaryngology, University of Oulu, Finland |
| Principal Investigator: | Aila Kristo, MD | Dept of Otolaryngology, University of Oulu, Finland |
| Principal Investigator: | Marjo Renko, PhD | Dept of pediatrics, University of Oulu, Finland |
| Principal Investigator: | Tero Kontiokari, PhD | Dept of pediatrics, University of Oulu, Finland |
| Principal Investigator: | Tytti Pokka, FK | Dept of pediatrics, University of Oulu, Finland |
More Information
| Study ID Numbers: | K53715 |
| Study First Received: | September 10, 2005 |
| Last Updated: | December 20, 2005 |
| ClinicalTrials.gov Identifier: | NCT00162994 |
| Health Authority: | Finland: National Agency for Medicines |
|
recurrent otitis media adenoidectomy tympanostomy |
young children prevention quality of life |
|
Otorhinolaryngologic Diseases Otitis Otitis Media |
Quality of Life Ear Diseases Recurrence |
