The Effects of Ventilation Tubes - The SIUTIT Trial

NCT02490332 | Terminated DMC

• 1 other identifier: 2015-112556
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

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.

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

• Number of visits to health clinic

  Assessed by investigating medical records.

  Two years after randomisation

Secondary Outcomes (4)

• Number of episodes of acute otitis media

  Two years after randomisation

• Quality of life

  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

  Two years after randomisation

• Proportion of children with uni- or bilateral tympanic membrane perforations

  Two years after randomisation

Other Outcomes (2)

• Number of episodes of aural discharge

  Two years after randomisation

• Serious adverse events

  During the trial

Study Arms (2)

Ventilation tube treatment

EXPERIMENTAL

Ventilation tube insertion in the tympanic membrane

Device: Ventilation tube treatment

Conservative treatment

NO INTERVENTION

Conventional treatment

Interventions

Ventilation tube treatment DEVICE

Tympanostomy

Also known as: Donaldson myringotomy tube

Ventilation tube treatment

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Government of Greenland, Agency for Health and Prevention: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (6)

Aasiaat Regional Hospital

Aasiaat, Danmark, 3950, Greenland

Location

Ilulissat Regional Hospital

Ilulissat, Danmark, 3952, Greenland

Location

Nuuk Health Center

Nuuk, Danmark, 3900, Greenland

Location

Sisimiut Regional Hospital

Sisimiut, Danmark, 3912, Greenland

Location

Tasiilaq Health Center

Tasiilaq, Danmark, 3913, Greenland

Location

Qaqortoq Regional Hospital

Qaqortoq, 3920, Greenland

Location

Related Publications (2)

• MacKeith S, Mulvaney CA, Galbraith K, Webster KE, Connolly R, Paing A, Marom T, Daniel M, Venekamp RP, Rovers MM, Schilder AG. Ventilation tubes (grommets) for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023 Nov 15;11(11):CD015215. doi: 10.1002/14651858.CD015215.pub2.

  PMID: 37965944 DERIVED

• 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.

  PMID: 28103950 DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Malene N Demant, MD

  Køge University Hospital

  PRINCIPAL INVESTIGATOR

• Preben Homoe, MD, PhD

  Køge University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: July 3, 2015
• Study Start: February 1, 2016
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

GR (6)