The Effects of Ventilation Tubes - The SIUTIT Trial

Otitis Media Clinical Trial

— SIUTIT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02490332
• Other study ID #: 2015-112556
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Device:
• Ventilation tube treatment
Tympanostomy

Locations

Country	Name	City	State
Greenland	Aasiaat Regional Hospital	Aasiaat	Danmark
Greenland	Ilulissat Regional Hospital	Ilulissat	Danmark
Greenland	Nuuk Health Center	Nuuk	Danmark
Greenland	Qaqortoq Regional Hospital	Qaqortoq
Greenland	Sisimiut Regional Hospital	Sisimiut	Danmark
Greenland	Tasiilaq Health Center	Tasiilaq	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Copenhagen Trial Unit, Center for Clinical Intervention Research, Government of Greenland, Agency for Health and Prevention

Country where clinical trial is conducted

Greenland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of episodes of aural discharge	According to medical records	Two years after randomisation
Other	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
Primary	Number of visits to health clinic	Assessed by investigating medical records.	Two years after randomisation
Secondary	Number of episodes of acute otitis media	According to medical records	Two years after randomisation
Secondary	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
Secondary	Number of episodes where per oral or intravenous antibiotics have been administered	According to medical records	Two years after randomisation
Secondary	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