Clinical trial NCT05348291: Effect of Ventilation Tubes in Otitis-prone Children
Official title: Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Acute Otitis Media
Keywords: ventilation tubes
prevention
quality of life
antibiotic treatment
otitis media with effusion
audiometry
watchful waiting
tympanic membrane perforation
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unblinded, randomised controlled trial.
Primary purpose: PREVENTION

Brief summary: 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.

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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Primary outcomes:
measure: Antibiotic prescriptions
timeFrame: First two years in study
measure: Otitis media episodes
timeFrame: First two years in study
Secondary outcomes:
measure: Microbiology
timeFrame: First two years in study
measure: Tympanic membrane perforations
timeFrame: Until age 7
measure: Audiometry
timeFrame: At age 4 and 7 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Otorhinolaryngology, Head and Neck Surgery
Study officials:
References: