Effect of Ventilation Tubes in Otitis-prone Children

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.

Detailed Description
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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.

Official Title
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Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes

Conditions
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Recurrent Acute Otitis Media

Intervention / Treatment
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* Device: ventilation tubes


Participation Criteria
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Eligibility Criteria
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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. - Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency -

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Unblinded, randomised controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ventilation tubes<br>Ventilation tube surgery | Device: ventilation tubes<br>* Transtympanic pressure equalising devices.<br>* Other names: grommets;|
| No Intervention: Active monitoring<br>Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic prescriptions | Number of oral antibiotic prescriptions | First two years in study | 
| Otitis media episodes | Number of otitis media episodes | First two years in study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiology | Nasopharyngeal and middle ear growth during acute otitis media episodes | First two years in study | 
| Tympanic membrane perforations | Presence of chronic tympanic membrane perforations | Until age 7 | 
| Audiometry | Audiometry, including high frequency audiometry | At age 4 and 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilation tubes, prevention, quality of life, antibiotic treatment, otitis media with effusion, audiometry, watchful waiting, tympanic membrane perforation