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Prevention Recurrent Otitis Media in the Young Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2002 by Oulu University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT00162994
First received: September 10, 2005
Last updated: December 20, 2005
Last verified: February 2002
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oulu University Hospital:

Primary Outcome Measures:
  • - number of acute otitis media
  • - quality of life issues

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

Estimated Enrollment: 300
Study Start Date: February 2002
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   10 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162994

Locations
Finland
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
Oulu University Hospital
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
  More Information

No publications provided by Oulu University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00162994     History of Changes
Other Study ID Numbers: K53715
Study First Received: September 10, 2005
Last Updated: December 20, 2005
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Oulu University Hospital:
recurrent otitis media
adenoidectomy
tympanostomy
 young children
prevention
quality of life

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013