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

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

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.

Study Overview

• Status: Terminated
• Conditions: Otitis Media
• Intervention / Treatment: Device: Ventilation tube treatment

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greenland
  • Qaqortoq, Greenland, 3920
    • Qaqortoq Regional Hospital
  • Danmark
    • Aasiaat, Danmark, Greenland, 3950
      • Aasiaat Regional Hospital
    • Ilulissat, Danmark, Greenland, 3952
      • Ilulissat Regional Hospital
    • Nuuk, Danmark, Greenland, 3900
      • Nuuk Health Center
    • Sisimiut, Danmark, Greenland, 3912
      • Sisimiut Regional Hospital
    • Tasiilaq, Danmark, Greenland, 3913
      • Tasiilaq Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventilation tube treatment; Ventilation tube insertion in the tympanic membrane	Device: Ventilation tube treatment; Tympanostomy; Other Names: Donaldson myringotomy tube
No Intervention: Conservative treatment; Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of visits to health clinic	Assessed by investigating medical records.	Two years after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of episodes of acute otitis media	According to medical records	Two years after randomisation
Quality of life	Measured by validated questionnaires OM6 and Caregiver Impact Questionnaire	Assessed at baseline, three months after randomisation, one year after randomisation, and at the end of the trial two years after randomisation
Number of episodes where per oral or intravenous antibiotics have been administered	According to medical records	Two years after randomisation
Proportion of children with uni- or bilateral tympanic membrane perforations	Based on otoscopical photos, which will be anonymised and evaluated by an ENT-specialist without knowledge of the intervention	Two years after randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of episodes of aural discharge	According to medical records	Two years after randomisation
Serious adverse events	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.	During the trial

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research; Government of Greenland, Agency for Health and Prevention
• Investigators: Principal Investigator: Malene N Demant, MD, Køge University Hospital; Study Director: Preben Homoe, MD, PhD, Køge University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: 2015-112556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final dataset will be publically available in depersonalised format after the end of trial on the Danish Data Archive and ZENODO.