Clinical trial NCT02490332: The Effects of Ventilation Tubes - The SIUTIT Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Otitis Media
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Government of Greenland, Agency for Health and Prevention
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2015-07-03
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion criteria:

* Children aged 9-36 months.
* Children with at least one Greenlandic born parent with at least one Greenlandic born parent
* American Society of Anaesthesiologists physical status classification class 1 and 2
* B- or C2 - type curve measured by tympanometry at two visits three-four months apart or three episodes of acute otitis media in six months according to medical records or four episodes of acute otitis media in 12 months according to medical records
* Signed informed consent, signed by the legal guardian Exclusion criteria
* Children with orofacial cleft, Downs syndrome or known generalised immune deficiency
* American Society of Anaesthesiologists physical status classification class \> 2.
* Lack of signed informed consent, signed by the legal guardian.

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.

Primary outcomes:
measure: Number of visits to health clinic
timeFrame: Two years after randomisation
Secondary outcomes:
measure: Number of episodes of acute otitis media
timeFrame: Two years after randomisation
measure: Quality of life
timeFrame: Assessed at baseline, three months after randomisation, one year after randomisation, and at the end of the trial two years after randomisation
measure: Number of episodes where per oral or intravenous antibiotics have been administered
timeFrame: Two years after randomisation
measure: Proportion of children with uni- or bilateral tympanic membrane perforations
timeFrame: Two years after randomisation
Other outcomes:
measure: Number of episodes of aural discharge
timeFrame: Two years after randomisation
measure: Serious adverse events
timeFrame: During the trial
Locations:
city: Aasiaat
country: Greenland
facility: Aasiaat Regional Hospital
state: Danmark
city: Ilulissat
country: Greenland
facility: Ilulissat Regional Hospital
state: Danmark
city: Nuuk
country: Greenland
facility: Nuuk Health Center
state: Danmark
city: Sisimiut
country: Greenland
facility: Sisimiut Regional Hospital
state: Danmark
city: Tasiilaq
country: Greenland
facility: Tasiilaq Health Center
state: Danmark
city: Qaqortoq
country: Greenland
facility: Qaqortoq Regional Hospital
Study officials:
affiliation: Køge University Hospital
name: Malene N Demant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Køge University Hospital
name: Preben Homoe, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Demant MN, Jensen RG, Jakobsen JC, Gluud C, Homoe P. 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, the SIUTIT trial: study protocol for a randomized controlled trial. Trials. 2017 Jan 19;18(1):30. doi: 10.1186/s13063-016-1770-x.