Effect of Ventilation Tubes in Otitis-prone Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ventilation tubes.
- Who it may be relevant to
- Registry conditions: Recurrent Acute Otitis Media. Basic parameters: 1 year — 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Overview
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
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.
Interventions
- Device ventilation tubes
Transtympanic pressure equalising devices.
Primary outcome measures
- Antibiotic prescriptions [Time frame: First two years in study]
- Otitis media episodes [Time frame: First two years in study]
Secondary outcome measures (3)
- Microbiology [Time frame: First two years in study]
- Tympanic membrane perforations [Time frame: Until age 7]
- Audiometry [Time frame: At age 4 and 7 years]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Department of Otorhinolaryngology, Head and Neck Surgery — Lund
Identifiers
NCT: NCT05348291 · Rorstudien2022