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

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

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

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

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Other: Data collection (Retrospective)
* Other: Data collection (Prospective)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol. A male or female subject aged < 6 years at the time of enrolment. The investigator has access to the medical records that contain the medical history of the subjects for one year prior to enrolment (for subjects aged 1 to < 6 years) or from birth (for subjects aged < 1 year). Written informed consent obtained from either both parents/ LARs or from one parent/ LAR of the subject with the declaration of cooperation for one year after enrolment. Exclusion Criteria: Acute otitis media episode at the time of enrolment. Upper respiratory tract infection at the time of enrolment.

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia). | Other: Data collection (Retrospective)<br>* 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.<br>Other: Data collection (Prospective)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by a family physician and documented in medical records - retrospective part of the study |  | Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year | 
| Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study |  | Prospective data for 12 months after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year |  | Prospective data for 12 months after study entry | 
| Occurrence of suspected acute otitis media as reported by the parent(s)/ legally acceptable representative(s) (and not diagnosed by any physician) during the bi-monthly follow-up |  | Prospective data for 12 months after study entry | 
| Occurrence of recurrent acute otitis media |  | Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry | 
| Occurrence of acute otitis media treatment failures |  | Prospective data for 12 months after study entry | 
| Assessment of the impact of acute otitis media on the quality of life of the subject and family by the parental quality of life questionnaire and the Otitis Media-6 children's quality of life questionnaire |  | Prospective data for 12 months after study entry | 
| Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media |  | Prospective data for 12 months after study entry | 
| Occurrence of acute otitis media as diagnosed by the study physician or any other doctor |  | Prospective data for 12 months after study entry | 
| Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures |  | Prospective data for 12 months after study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incidence, otitis, observational, Epidemiological, retrospective, prospective