Prevention Recurrent Otitis Media in the Young Children
Primary Purpose
Otitis Media
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
adenoidectomy and tymapanostomy
Sponsored by
About this trial
This is an interventional prevention trial for Otitis Media focused on measuring recurrent otitis media, adenoidectomy, tympanostomy, young children, prevention, quality of life
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
Sites / Locations
- Oulu University Hospital
Outcomes
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
Full Information
NCT ID
NCT00162994
First Posted
September 10, 2005
Last Updated
December 20, 2005
Sponsor
Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00162994
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2002
Overall Recruitment Status
Unknown status
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oulu University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
recurrent otitis media, adenoidectomy, tympanostomy, young children, prevention, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
adenoidectomy and tymapanostomy
Primary Outcome Measure Information:
Title
- number of acute otitis media
Title
- quality of life issues
Secondary Outcome Measure Information:
Title
- time to first recurrence
Title
- speed of recovery of each otitis media
Title
- number of days of middle ear effusion
Title
- number of upper respiratory infections
Title
- prevention of otitis media caused by pnemococcus in carrier of pneumococcus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petri Koivunen, PhD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, professor
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matti Uhari, professor
Organizational Affiliation
Dept of Pediatrics, University of Oulu, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tiia Kujala, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jukka Luotonen, PhD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aila Kristo, MD
Organizational Affiliation
Dept of Otolaryngology, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjo Renko, PhD
Organizational Affiliation
Dept of pediatrics, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tero Kontiokari, PhD
Organizational Affiliation
Dept of pediatrics, University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tytti Pokka, FK
Organizational Affiliation
Dept of pediatrics, University of Oulu, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24445832
Citation
Kujala T, Alho OP, Kristo A, Uhari M, Renko M, Pokka T, Koivunen P. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014 Jul;33(7):715-9. doi: 10.1097/INF.0000000000000265.
Results Reference
derived
PubMed Identifier
22466327
Citation
Kujala T, Alho OP, Luotonen J, Kristo A, Uhari M, Renko M, Kontiokari T, Pokka T, Koivunen P. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J. 2012 Jun;31(6):565-9. doi: 10.1097/INF.0b013e318255ddde.
Results Reference
derived
Learn more about this trial
Prevention Recurrent Otitis Media in the Young Children
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