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The Effects of Ventilation Tubes - The SIUTIT Trial (SIUTIT)

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ClinicalTrials.gov Identifier: NCT02490332
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
Government of Greenland, Agency for Health and Prevention
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Malene Nøhr Demant, 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.


Condition or disease Intervention/treatment Phase
Otitis Media Device: Ventilation tube treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Ventilation tube treatment
Ventilation tube insertion in the tympanic membrane
Device: Ventilation tube treatment
Tympanostomy
Other Name: Donaldson myringotomy tube

No Intervention: Conservative treatment
Conventional treatment



Primary Outcome Measures :
  1. Number of visits to health clinic [ Time Frame: Two years after randomisation ]
    Assessed by investigating medical records.


Secondary Outcome Measures :
  1. Number of episodes of acute otitis media [ Time Frame: Two years after randomisation ]
    According to medical records

  2. 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

  3. Number of episodes where per oral or intravenous antibiotics have been administered [ Time Frame: Two years after randomisation ]
    According to medical records

  4. 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


Other Outcome Measures:
  1. Number of episodes of aural discharge [ Time Frame: Two years after randomisation ]
    According to medical records

  2. 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.



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Ages Eligible for Study:   9 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Contacts
Contact: Malene N Demant, MD +4530241425 siutit@peqqik.gl

Locations
Greenland
Aasiaat Regional Hospital Recruiting
Aasiaat, Danmark, Greenland, 3950
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Ilulissat Regional Hospital Recruiting
Ilulissat, Danmark, Greenland, 3952
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Nuuk Health Center Recruiting
Nuuk, Danmark, Greenland, 3900
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Sisimiut Regional Hospital Recruiting
Sisimiut, Danmark, Greenland, 3912
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Tasiilaq Health Center Recruiting
Tasiilaq, Danmark, Greenland, 3913
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Qaqortoq Regional Hospital Recruiting
Qaqortoq, Greenland, 3920
Contact: Malene N Demant    30241425    siutit@peqqik.gl   
Sponsors and Collaborators
Zealand University Hospital
Government of Greenland, Agency for Health and Prevention
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
Principal Investigator: Malene N Demant, MD Køge University Hospital
Study Director: Preben Homoe, MD, PhD Køge University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malene Nøhr Demant, MD, PhD-student, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02490332     History of Changes
Other Study ID Numbers: 2015-112556
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final dataset will be publically available in depersonalised format after the end of trial on the Danish Data Archive and ZENODO.

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases