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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 24, 2019
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

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date January 24, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2016)
Number of visits to health clinic [ Time Frame: Two years after randomisation ]
Assessed by investigating medical records.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • Perforation of the tympanic membrane [ Time Frame: Three years after intervention ]
    Assessed by video otoscopy by blinded assessors. Perforation yes/no.
  • Episodes of ear discharge [ Time Frame: Three years ]
    From medical records
  • Otitis media with effusion at age 4 [ Time Frame: Three years after intervention ]
    As detemined by otoscopy and tympanometry
  • Episodes of Acute otitis media [ Time Frame: Three years ]
    From medical records
Change History Complete list of historical versions of study NCT02490332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2015)
  • Quality of life (OM6 and Caregiver Impact Questionnaire) [ Time Frame: Three years ]
    Questionnaires, assessed every year
  • Hearing impairment [ Time Frame: Three years after intervention ]
    Assessed by pure tone audiometry, normal hearing defined by > 20 dB
  • Association to known risk factors [ Time Frame: Three years ]
    Questionnaires, assessed every year
  • Microbiological assessment [ Time Frame: At intervention ]
    PCR for bacterial 16S RNA in ear fluid
  • Test of balance [ Time Frame: Three years after intervention ]
    Bruininks-Oseretskys test of motor deficiency
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2016)
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Ventilation Tubes - The SIUTIT Trial
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Otitis Media
Intervention  ICMJE Device: Ventilation tube treatment
Tympanostomy
Other Name: Donaldson myringotomy tube
Study Arms  ICMJE
  • Experimental: Ventilation tube treatment
    Ventilation tube insertion in the tympanic membrane
    Intervention: Device: Ventilation tube treatment
  • No Intervention: Conservative treatment
    Conventional treatment
Publications * Demant MN, Jensen RG, Jakobsen JC, Gluud C, Homøe 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2016)
230
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2015)
400
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malene N Demant, MD +4530241425 siutit@peqqik.gl
Listed Location Countries  ICMJE Greenland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02490332
Other Study ID Numbers  ICMJE 2015-112556
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Malene Nøhr Demant, Zealand University Hospital
Study Sponsor  ICMJE Zealand University Hospital
Collaborators  ICMJE
  • Government of Greenland, Agency for Health and Prevention
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators  ICMJE
Principal Investigator: Malene N Demant, MD Køge University Hospital
Study Director: Preben Homoe, MD, PhD Køge University Hospital
PRS Account Zealand University Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP