Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT02490332
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
36 Months
Study:
NCT02490332
Study Brief:
Protocol Section:
NCT02490332