The Effects of Ventilation Tubes - The SIUTIT Trial
- Conditions
- Otitis Media
- Interventions
- Device: Ventilation tube treatment
- Registration Number
- NCT02490332
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ventilation tube treatment Ventilation tube treatment Ventilation tube insertion in the tympanic membrane
- Primary Outcome Measures
Name Time Method Number of visits to health clinic Two years after randomisation Assessed by investigating medical records.
- Secondary Outcome Measures
Name Time Method Number of episodes of acute otitis media Two years after randomisation According to medical records
Quality of life Assessed at baseline, three months after randomisation, one year after randomisation, and at the end of the trial two years after randomisation Measured by validated questionnaires OM6 and Caregiver Impact Questionnaire
Number of episodes where per oral or intravenous antibiotics have been administered Two years after randomisation According to medical records
Proportion of children with uni- or bilateral tympanic membrane perforations Two years after randomisation Based on otoscopical photos, which will be anonymised and evaluated by an ENT-specialist without knowledge of the intervention
Trial Locations
- Locations (6)
Aasiaat Regional Hospital
🇬🇱Aasiaat, Danmark, Greenland
Ilulissat Regional Hospital
🇬🇱Ilulissat, Danmark, Greenland
Tasiilaq Health Center
🇬🇱Tasiilaq, Danmark, Greenland
Nuuk Health Center
🇬🇱Nuuk, Danmark, Greenland
Sisimiut Regional Hospital
🇬🇱Sisimiut, Danmark, Greenland
Qaqortoq Regional Hospital
🇬🇱Qaqortoq, Greenland