An interventional study of ventilation tubes in Recurrent Acute Otitis Media, sponsored by Lund University. Recruiting at 1 site in Sweden. Open to participants aged 1 Year to 2 Years. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Lund University · Not applicable, Interventional, and Prevention
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.
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 150 is close to the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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Ventilation tube surgery
Device: ventilation tubes
Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.
Transtympanic pressure equalising devices.
Also known as: grommets
Antibiotic prescriptions
Number of oral antibiotic prescriptions
Time frame: First two years in study
Otitis media episodes
Number of otitis media episodes
Time frame: First two years in study
Microbiology
Nasopharyngeal and middle ear growth during acute otitis media episodes
Time frame: First two years in study
Tympanic membrane perforations
Presence of chronic tympanic membrane perforations
Time frame: Until age 7
Audiometry
Audiometry, including high frequency audiometry
Time frame: At age 4 and 7 years
Started Oct 2022 (actual). Primary completion is estimated for May 2028, 67 months after the start.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 67 months is above that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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