NCT01365390已完成不适用
To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,258
- 试验地点
- 1
- 主要终点
- Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
研究概览
简要总结
The aim of this study is to provide baseline acute otitis media data in East European countries.
详细描述
Each subject's involvement in this study will include a retrospective and prospective part.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Acute otitis media episode at the time of enrolment.
- •Upper respiratory tract infection at the time of enrolment.
结局指标
主要结局
Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
时间窗: Prospective data for 12 months after study entry
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
时间窗: 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
次要结局
- 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)
- 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)
- Occurrence of acute otitis media as diagnosed by the study physician or any other doctor(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)
- 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 treatment failures(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)
研究者
研究点 (1)
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