Prevention Recurrent Otitis Media in the Young Children - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 10, 2005

Last Updated Date

December 20, 2005

Start Date ^†

February 2002

Current Primary Outcome Measures ^†

- number of acute otitis media
- quality of life issues

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00162994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

- 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Prevention Recurrent Otitis Media in the Young Children

Official Title ^†

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

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 Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Otitis Media

Intervention ^†

Procedure: adenoidectomy and tymapanostomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

300

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

10 Months to 24 Months

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Finland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162994

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Oulu University Hospital

Collaborators ^††

Investigators ^†

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

Information Provided By

Oulu University Hospital

Verification Date

February 2002

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.