To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
NCT ID: NCT01365390
Last Updated: 2014-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2258 participants
OBSERVATIONAL
2011-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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Cohort A
Subjects aged \< 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia).
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Upper respiratory tract infection at the time of enrolment.
6 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Vilnius, , Lithuania
GSK Investigational Site
Vilnius, , Lithuania
GSK Investigational Site
Vilnius, , Lithuania
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Dębica, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Kielce, , Poland
GSK Investigational Site
Siemianowice Śląskie, , Poland
GSK Investigational Site
Tarnów, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Wejherowo, , Poland
GSK Investigational Site
Wola, , Poland
GSK Investigational Site
Łęczna, , Poland
GSK Investigational Site
Bacau, , Romania
GSK Investigational Site
Brasov, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Craiova, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Ljubljana, , Slovenia
GSK Investigational Site
Ljubljana, , Slovenia
GSK Investigational Site
Maribor, , Slovenia
GSK Investigational Site
Maribor, , Slovenia
GSK Investigational Site
Ptuj, , Slovenia
GSK Investigational Site
Ruše, , Slovenia
Countries
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References
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Usonis V, Jackowska T, Petraitiene S, Sapala A, Neculau A, Stryjewska I, Devadiga R, Tafalla M, Holl K. Incidence of acute otitis media in children below 6 years of age seen in medical practices in five East European countries. BMC Pediatr. 2016 Jul 26;16:108. doi: 10.1186/s12887-016-0638-2.
Other Identifiers
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115356
Identifier Type: -
Identifier Source: org_study_id
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