Otitis MediaSIUTITNCT02490332
The Effects of Ventilation Tubes - The SIUTIT Trial
A study testing Ventilation tube treatment in people with Otitis Media, run by Zealand University Hospital at 6 sites in Greenland.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 36 months
- Conditions the study is for
- Otitis Media
- What is being tested?
- Ventilation tube treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesGreenland
- Study dates
- Feb 2016to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greenland6 sites
Aasiaat Regional Hospital
Aasiaat, Danmark, 3950
Ilulissat Regional Hospital
Ilulissat, Danmark, 3952
Nuuk Health Center
Nuuk, Danmark, 3900
Qaqortoq Regional Hospital
Qaqortoq, 3920
Sisimiut Regional Hospital
Sisimiut, Danmark, 3912
Tasiilaq Health Center
Tasiilaq, Danmark, 3913
About this study
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
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
Read more
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
- Being tested
- Ventilation tube treatment
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation tube treatmentDevice
Also called Donaldson myringotomy tube
Tympanostomy
| Study group | Role | What they receive |
|---|---|---|
| Ventilation tube treatment | Experimental | Ventilation tube insertion in the tympanic membrane Receives: Device: Ventilation tube treatment |
| Conservative treatment | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of visits to health clinic
Assessed by investigating medical records.
Measured: Two years after randomisation
Secondary outcomes (4)
Number of episodes of acute otitis media
According to medical records
Measured: Two years after randomisation
Quality of life
Measured by validated questionnaires OM6 and Caregiver Impact Questionnaire
Measured: 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
Measured: 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
Measured: Two years after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Failed to include the required number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Greenland, Agency for Health and Prevention, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Principal investigator, Malene Nøhr Demant, Zealand University Hospital
- Investigators
- Malene N Demant, MD, Principal investigator, Køge University HospitalPreben Homoe, MD, PhD, Study director, Køge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490332
- Sponsor's protocol ID
- 2015-112556
- Other IDs
- 2015
- Acronym
- SIUTIT
- Status last verified
- Nov 2020
- First submitted
- 3 Jun 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The final dataset will be publically available in depersonalised format after the end of trial on the Danish Data Archive and ZENODO.
Publications
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.
PubMed 37965944Demant 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.
PubMed 28103950
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02490332
- Acronym / sponsor ID
- SIUTIT / 2015-112556
- Conditions
- Otitis Media
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to include the required number of participants
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Government of Greenland, Agency for Health and Prevention, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Feb 2016
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilation tube treatment | Experimental | Device: Ventilation tube treatmentVentilation tube insertion in the tympanic membrane |
| Conservative treatment | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation tube treatmentAlso: Donaldson myringotomy tubeTympanostomy | Device | Ventilation tube treatment |
Primary outcome
Number of visits to health clinic
Time frame: Two years after randomisation
Assessed by investigating medical records.
4 secondary outcomes
Number of episodes of acute otitis media
Time frame: Two years after randomisation
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
Number of episodes where per oral or intravenous antibiotics have been administered
Time frame: Two years after randomisation
Proportion of children with uni- or bilateral tympanic membrane perforations
Time frame: Two years after randomisation
Results and safety
The study was stopped early (reason given: Failed to include the required number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 37965944MacKeith 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.
- Derived from this study: PubMed 28103950Demant 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.
- Individual participant dataSharing planned: Yes. The final dataset will be publically available in depersonalised format after the end of trial on the Danish Data Archive and ZENODO.
Related trials for Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malene N Demant, MD principal investigator
Køge University Hospital
Preben Homoe, MD, PhD study director
Køge University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation tube treatment in people with Otitis Media, run by Zealand University Hospital at 6 sites in Greenland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greenland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failed to include the required number of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of visits to health clinic (time frame: Two years after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.