Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
31 participants
INTERVENTIONAL
2016-02-29
2020-11-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ventilation tube treatment
Ventilation tube insertion in the tympanic membrane
Ventilation tube treatment
Tympanostomy
Conservative treatment
Conventional treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ventilation tube treatment
Tympanostomy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
9 Months
36 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Government of Greenland, Agency for Health and Prevention
UNKNOWN
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Zealand University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Malene Nøhr Demant
MD, PhD-student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Malene N Demant, MD
Role: PRINCIPAL_INVESTIGATOR
Køge University Hospital
Preben Homoe, MD, PhD
Role: STUDY_DIRECTOR
Køge University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aasiaat Regional Hospital
Aasiaat, Danmark, Greenland
Ilulissat Regional Hospital
Ilulissat, Danmark, Greenland
Nuuk Health Center
Nuuk, Danmark, Greenland
Sisimiut Regional Hospital
Sisimiut, Danmark, Greenland
Tasiilaq Health Center
Tasiilaq, Danmark, Greenland
Qaqortoq Regional Hospital
Qaqortoq, , Greenland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-112556
Identifier Type: -
Identifier Source: org_study_id