ACTRN12611001073998撤回4 期
A 12 month, multi-centred, randomized trial to compare the outcomes of two surgical and one medical intervention on chronic Otitis Media in Indigenous children living in remote communities of Australia. Medicine V surgery sub-study
niversity of Melbourne0 个研究点目标入组 200 人开始时间: 2011年10月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Years 至 10 Years（—）
- 性别
- All
入选标准
- •Indigenous & non-indigenous children aged 3-10 years living in remote Australian communities.
- •Otitis Media with effusion / recurrent Acute Otitis Media (OME /rAOM) for greater than 3 months and failed medical treatment.
- •Glue ear (immovable tympanic membrane) determined by tympanometry & otoscopy
- •Mild or moderate conductive hearing impairment (>15dB in soundproof room or >25db in non-sound proof)
排除标准
- •Children with conditions which may predispose to post-op complications eg: cleft palate, Downes syndrome, generalised immunolgical conditions
研究者
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