Trials / Completed

CompletedNCT01365390

To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries

To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries

Summary

The aim of this study is to provide baseline acute otitis media data in East European countries.

Each subject's involvement in this study will include a retrospective and prospective part.

Type	Name	Description
OTHER	Data collection (Retrospective)	For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to \< 6 years) or since birth (for subjects aged \< 1 year) will be recorded in the electronic case report form.
OTHER	Data collection (Prospective)	For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.

25 sites across 5 countries: Estonia, Lithuania, Poland, Romania, Slovenia

Source: ClinicalTrials.gov record NCT01365390. Inclusion in this directory is not an endorsement.