NCT00960102Unknown不适用
Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Kuopio University Hospital6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
研究概览
简要总结
The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital severe or profound bilateral hearing impairment
- •No functional benefit from conventional hearing aids (minimum 3 months trial)
- •Radiologically (CT,MRI) patent inner ears and normal central auditory pathways
- •Family is motivated for rehabilitation programme and gives a written consent
- •Finnish or Swedish as the primary language in the home
排除标准
- •A child has an additional anomaly or disability that may affect to his/her functional or neurological development
- •Inner ear anomaly
- •Mother's pregnancy duration less than 32 weeks
结局指标
主要结局
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids
时间窗: Various time points up to 5 years hearing age
次要结局
- To evaluate the differences in balance function(at 3 and 5 year age)
- Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment(Various time points up to 5 years hearing age)
- To evaluate operative and post-operative complications, side-effects and device failures(Various time points up to 5 years hearing age)
- To compare post-operative speech perception ability, language acquisition, and speech production(Various time points up to 5 years hearing age)
- To compare speech recognition performance(Various time points up to 5 years hearing age)
研究者
Heikki Lopponen
M.D.,Prof.
Kuopio University Hospital
研究点 (6)
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