ACTRN12617001652369已完成未知
A multi-centre randomised controlled trial to compare nasal balloon autoinflation versus no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
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 16 Years（—）
- 性别
- All
入选标准
- •1. Aboriginal and Torres Strait Islander
- •2. Aged 3 -16 years
- •3. Type B tympanogram in at least one ear
排除标准
- •Child has current acute upper respiratory infection;
- •Current acute otitis media (defined as a Type B tympanogram plus either ear pain or a bulging ear drum on otoscopy);
- •Current perforated tympanic membrane or current grommet (ventilation tube);
- •Planned ENT surgery within next 1 month;
- •Children with a latex allergy;
- •A nosebleed in the last 3 weeks, or more than 1 nosebleed in the preceding 6 months;
- •A condition which increases the risk of complications (e.g. immunosuppression, genetic or chromosomal abnormality, cleft palate or mid-face abnormalities such as seen in Down Syndrome)
- •Inability to use the autoinflation device.
- •Previous participation in INFLATE
研究者
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