Randomized Control Trial to Analyse the Effect of Intra Operative Switch On (IOSO) of Cochlear Implant as Compared To Delayed Switch On of Cochlear Implant On Electrical Impedance Measurement and Auditory Skills Development In Pediatric Patients With Congenital Profound Idiopathic Non-Syndromic SNHL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- patients who undergo IOSO and those with
研究概览
简要总结
The study aims to improve the existing approach of Cochlear Implant technique. The patient will be enrolled in two groups will, one in which Cochlear Implant machine will
be Switched On 2-4 weeks after the surgery , and the child will start hearing after 2- 4 weeks which is the conventional approach being used . Second Group will include children
who will receive new approach of Cochlear Implant technique of switching it on during the surgery only i.e. the child will start hearing immediately after the surgery. Two groups will
be compared and will be followed for a period of 6 months after the surgery, where child will be assessed for how early he/she is able to listen and respond to the surroundings
and how better his learning is . Also, the effect of this new approach on expenses incurred by parents as well as hospital will be studied . The effect of this approach on the battery
life and durability of the device will be also be studied and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Pediatric patient between Age 9 Months to 5 years with suitable Candidacy AND Patient with Congenital Idiopathic Profound SNHL planned for Cochlear Implant with caregivers willing for Follow up Of 6 Months.
排除标准
- •Patient with significant cognitive impairment which may affect speech and language development AND Intraoperative complications during surgery that may preclude IOSO.
结局指标
主要结局
patients who undergo IOSO and those with
时间窗: 6 MONTHS
delayed Switch ON (between 2wks-4wks)
时间窗: 6 MONTHS
To Compare Electrical Impedance of
时间窗: 6 MONTHS
Cochlear Implant electrodes between
时间窗: 6 MONTHS
次要结局
- To assess the Auditory outcome(between two groups using)
- Impact of early switch ON the(battery usage of the implant as)
- To observe complications related to(wound healing for both the groups)
- To assess the cost incurred by the(hospital and family of the children)
研究者
Dr Swapnil Agarwal
AIIMS , New Delhi