ACTRN12613000102774招募中未知
This 12 month,surgical sub-study is a multi-centred, randomized trial to compare the outcomes of two surgical interventions on chronic Otitis Media in Indigenous children living in remote communities of Australia
niversity of Melbourne0 个研究点目标入组 280 人开始时间: 2013年1月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 280
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
- Open (masking not used)
入排标准
- 年龄范围
- 3 Years 至 10 Years（—）
- 性别
- All
入选标准
- •Indigenous children aged 3 - 10 years old living in remote communities
- •- OME/AOM that has been present for greater than or equal to 6 months and failed medical treatment. The criteria for the diagnosis of glue ear will be the presence of an immobile tympanic membrane on pneumatic otoscopy, supported by an air-bone gap on audiometry and a Type B tympanogram.
- •- A mild or moderate conductive hearing impairment, defined as a pure-tone average of greater than or equal to 20 dB when tested in a sound-proofed room, or greater than 30dB when tested in non sound-proofed conditions.
- •Approximately 70% of children with OME/AOM are expected to meet this criterion.
排除标准
- •Children with any of the following conditions which may predispose to complications following adenoidectomy:
- •Cleft palate
- •Submucous cleft palate
- •Down Syndrome
- •Cranio-facial syndromes
- •Generalised immunological diseases
- •Bleeding diasthesis
- •Requirement for concomitant tonsillectomy
- •Also exclude Children requiring treatment of unilateral ear pathology
研究者
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