Effect of Ventilation Tubes in Otitis-prone Children

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.

Full Title of Study: “Ventilation Tubes for Recurrent Acute Otitis Media – Effects on Antibiotic Consumption and Otitis Media Episodes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2028

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 childĀ“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.

Arms, Groups and Cohorts

  • Active Comparator: Ventilation tubes
    • Ventilation tube surgery
  • No Intervention: Active monitoring
    • Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.

Clinical Trial Outcome Measures

Primary Measures

  • Antibiotic prescriptions
    • Time Frame: First two years in study
    • Number of oral antibiotic prescriptions
  • Otitis media episodes
    • Time Frame: First two years in study
    • Number of otitis media episodes

Secondary Measures

  • Microbiology
    • Time Frame: First two years in study
    • Nasopharyngeal and middle ear growth during acute otitis media episodes
  • Tympanic membrane perforations
    • Time Frame: Until age 7
    • Presence of chronic tympanic membrane perforations
  • Audiometry
    • Time Frame: At age 4 and 7 years
    • Audiometry, including high frequency audiometry
  • Quality of life
    • Time Frame: First two years in study
    • Quality of life of children and parents according to OMQ-7

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: 1 Year

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lund University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Marie Gisselsson-Solen, MD, PhD, +4646172815, marie.gisselsson-solen@med.lu.se

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