Prevention Recurrent Otitis Media in the Young Children

December 20, 2005 updated by: Oulu University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- number of acute otitis media
- quality of life issues

Secondary Outcome Measures

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oulu University Hospital

Investigators

  • Principal Investigator: Aila Kristo, MD, Dept of Otolaryngology, University of 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2005

Last Update Submitted That Met QC Criteria

December 20, 2005

Last Verified

February 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K53715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Otitis Media

Clinical Trials on adenoidectomy and tymapanostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe