An interventional study of Ventilation tube treatment in Otitis Media, sponsored by Zealand University Hospital. Terminated at 6 sites in Greenland. Open to participants aged 9 Months to 36 Months. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Prevention
The prevalence of otitis media among Greenlandic children is one of the highest in the world and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic children. International studies from the developed part of the world have shown that otitis prone children may benefit from tubulation of the tympanic membrane. However, it is unknown if these results can be applied to Greenlandic children.
This PhD project will conduct a randomised controlled trial comparing tubulation of the tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media and/or chronic otitis media with effusion, to conservative treatment. The children will be followed for two years. Outcome measures will include number of visits to health clinics, number of tympanic membrane perforations, number of episodes with acute otitis media according to medical records, Quality of life, measured by the validated questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous antibiotics have been administered according to medical records and serious adverse events
The trial will be conducted in collaboration with the Greenlandic health authorities and Copenhagen Trial Unit.
With this trial the investigators hope to decrease the number of episodes with acute otitis media, the number of Greenlandic children with chronic perforations of the tympanic membrane and hearing impairment and increase quality of life.
The results will add important knowledge to the effect of ventilation tube treatment also in an international aspect. There are to date only less than a handful of high quality studies concerning this issue on an international basis. The study will be among the first addressing this problem among populations with high risk of otitis media and is also of interest to other indigenous populations and the developing part of the world.
246 studies on the registry are indexed under Otitis; 21 are open to participants now.
This study's enrollment of 31 is below the median of 126 across 173 interventional studies indexed under Otitis.
Browse Otitis studies →Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Description of experimental and control intervention Experimental intervention: The intervention group will be treated with bilateral Donaldson ventilation tubes administered in general anaesthesia Control intervention: The control intervention is based on the current practice in Greenland, which includes systemic antibiotic treatment as well as aural toilette and topical antibiotics. Ventilation tube insertion during the study period is not accepted in the control group.
Children in the intervention group as well as the control group will be seen once a year by the visiting ear-nose-and throat (ENT)-specialist and have a final consultation after at least two years after randomisation.
Ventilation tube insertion in the tympanic membrane
Device: Ventilation tube treatment
Conventional treatment
Tympanostomy
Also known as: Donaldson myringotomy tube
Number of visits to health clinic
Assessed by investigating medical records.
Time frame: Two years after randomisation
Number of episodes of acute otitis media
According to medical records
Time frame: Two years after randomisation
Quality of life
Measured by validated questionnaires OM6 and Caregiver Impact Questionnaire
Time frame: Assessed at baseline, three months after randomisation, one year after randomisation, and at the end of the trial two years after randomisation
Number of episodes where per oral or intravenous antibiotics have been administered
According to medical records
Time frame: Two years after randomisation
Proportion of children with uni- or bilateral tympanic membrane perforations
Based on otoscopical photos, which will be anonymised and evaluated by an ENT-specialist without knowledge of the intervention
Time frame: Two years after randomisation
Number of episodes of aural discharge
According to medical records
Time frame: Two years after randomisation
Serious adverse events
Any adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, or results in persistent or significant disability or incapacity.
Time frame: During the trial
Plan to share: Yes — The final dataset will be publically available in depersonalised format after the end of trial on the Danish Data Archive and ZENODO.
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital