Effect of Ventilation Tubes in Otitis-prone Children
Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the nature of the intervention, blinding will not be possible. Children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups.
Children will be followed by the study doctors every third month until the age of two years, and after this yearly. In addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of AOM. Otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. It will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of AOM or of otitis media with effusion (OME). At each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. It will be noted how many AOM episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than AOM), and if the family has seen a doctor elsewhere. At each emergency visit, it will be noted if the child has AOM or not, whether the child has fever, any signs of complications to AOM, a spontaneous perforation and whether the child´s general well-being is affected.
At the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie Gisselsson-Solen, MD, PhD
- Phone Number: +4646172815
- Email: marie.gisselsson-solen@med.lu.se
Study Contact Backup
- Name: Ann Hermansson, Professor
- Phone Number: +4646171360
- Email: ann.hermansson@med.lu.se
Study Locations
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Lund, Sweden, 22185
- Recruiting
- Department of Otorhinolaryngology, Head and Neck Surgery
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Contact:
- Tomas Andersson-Kronmark, MD
- Email: tomas.kronmark@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: At inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent AOM, ie have had 3 episodes of AOM during the last 6 months, or 4 during the last 12 months.
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Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ventilation tubes
Ventilation tube surgery
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Transtympanic pressure equalising devices.
Other Names:
|
|
No Intervention: Active monitoring
Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antibiotic prescriptions
Time Frame: First two years in study
|
Number of oral antibiotic prescriptions
|
First two years in study
|
|
Otitis media episodes
Time Frame: First two years in study
|
Number of otitis media episodes
|
First two years in study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbiology
Time Frame: First two years in study
|
Nasopharyngeal and middle ear growth during acute otitis media episodes
|
First two years in study
|
|
Tympanic membrane perforations
Time Frame: Until age 7
|
Presence of chronic tympanic membrane perforations
|
Until age 7
|
|
Audiometry
Time Frame: At age 4 and 7 years
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Audiometry, including high frequency audiometry
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At age 4 and 7 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rorstudien2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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