The Effects of Ventilation Tubes - The SIUTIT Trial (SIUTIT)
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|ClinicalTrials.gov Identifier: NCT02490332|
Recruitment Status : Terminated (Failed to include the required number of participants)
First Posted : July 3, 2015
Last Update Posted : November 4, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Device: Ventilation tube treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of Ventilation Tubes Versus no Ventilation Tubes for Recurrent Acute Otitis Media or Chronic Otitis Media With Effusion in 9 to 36 Month Old Greenlandic Children - a Randomised Clinical Trial|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2, 2020|
|Actual Study Completion Date :||November 2, 2020|
Experimental: Ventilation tube treatment
Ventilation tube insertion in the tympanic membrane
Device: Ventilation tube treatment
Other Name: Donaldson myringotomy tube
No Intervention: Conservative treatment
- Number of visits to health clinic [ Time Frame: Two years after randomisation ]Assessed by investigating medical records.
- Number of episodes of acute otitis media [ Time Frame: Two years after randomisation ]According to medical records
- Quality of life [ Time Frame: 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 [ Time Frame: Two years after randomisation ]According to medical records
- Proportion of children with uni- or bilateral tympanic membrane perforations [ Time Frame: Two years after randomisation ]Based on otoscopical photos, which will be anonymised and evaluated by an ENT-specialist without knowledge of the intervention
- Number of episodes of aural discharge [ Time Frame: Two years after randomisation ]According to medical records
- Serious adverse events [ Time Frame: During the trial ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490332
|Aasiaat Regional Hospital|
|Aasiaat, Danmark, Greenland, 3950|
|Ilulissat Regional Hospital|
|Ilulissat, Danmark, Greenland, 3952|
|Nuuk Health Center|
|Nuuk, Danmark, Greenland, 3900|
|Sisimiut Regional Hospital|
|Sisimiut, Danmark, Greenland, 3912|
|Tasiilaq Health Center|
|Tasiilaq, Danmark, Greenland, 3913|
|Qaqortoq Regional Hospital|
|Qaqortoq, Greenland, 3920|
|Principal Investigator:||Malene N Demant, MD||Køge University Hospital|
|Study Director:||Preben Homoe, MD, PhD||Køge University Hospital|