Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- - quality of life issues
研究概览
简要总结
The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.
详细描述
Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.
In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 10 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 3 otitis media episodes during the last half year
- •address near (< 50 km) the university hospital of Oulu
排除标准
- •otitis media effusion lasting longer than two months without acute exacerbations
- •prior adenoidectomy or tympanostomy
- •head or neck malformation
- •retarded child
- •serious disease
- •chemoprophylaxis for another disease
结局指标
主要结局
- quality of life issues
- number of acute otitis media
次要结局
- - time to first recurrence
- - speed of recovery of each otitis media
- - number of days of middle ear effusion
- - number of upper respiratory infections
- - prevention of otitis media caused by pnemococcus in carrier of pneumococcus