OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- auditory development
研究概览
简要总结
Children with special needs require complex, individualized therapy to maximize their long-term quality of life. One subset of children with special needs includes those with both developmental delays and deafness. Currently, there is little compelling evidence supporting the idea that cochlear implantation provides benefit to children that don't have the cognitive potential to develop normal speech and language.
We will perform a prospective, randomized clinical trial to answer the question of which intervention provides more benefit to this population of children using validated, norm-referenced tests.
Our long-term goal is to develop guidelines that may help when selecting a treatment for hearing loss in a child with developmental delays.
This proposal is significant because children with special needs are deserving of evidence upon which to base treatment decision-making, but remain under-represented in the medical literature and are often not studied. This research is designed to meet the criteria for the National Institutes of Health road map because it will generate this type of objective evidence that can directly improve patient care.
详细描述
This will be a prospective, randomized clinical trial. Deaf children (and their parent or guardians) who meet the criteria for developmental delays (as well as the other inclusion and exclusion criteria) will be randomly assigned to receive either hearing aids (group 1) or a cochlear implant (group 2) and followed longitudinally for two years. If one intervention provides improved development and quality of life over the other, this study will provide essential evidence to support clinical decision-making in this population. Children with normal cognition undergoing cochlear implantation will be studied as a control cohort (group 3) in order to demonstrate to what extent the gains after cochlear implantation in children with developmental delays parallel the gains seen in children without developmental delays. There is no placebo group.
Specific aim 1: We will compare the changes in development between the groups. If our hypothesis is true, auditory, linguistic, and cognitive development should demonstrate more improvement in deaf children with developmental delays treated with cochlear implantation compared to those treated with hearing aids.
Specific aim 2: We will compare the changes in quality of life between the groups. If our hypothesis is true, quality of life should demonstrate more improvement in patients treated with cochlear implantation compared to those treated with hearing aids.
Screening will be performed by the Principal Investigator (PI), his collaborators, and his research staff at the Children's Hearing Center at Lucile Packard Children's Hospital (LPCH).
In order to minimize investigator selection bias and in an attempt to produce study groups that are comparable, this is a randomized study. Randomization does not guarantee comparable study groups, particularly in a small trial like this. In order to improve the odds of achieving comparable study groups, we have elected to stratify the randomization process by age. Also, a block randomization process will be used. Lastly, we will compare the groups at the end of the study by looking at their baseline assessment data and stratifying the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet audiometric criteria for cochlear implantation
- •Age <3 by the time of initiation of treatment
- •Ability to return for follow-up evaluations at the one and two year time points
排除标准
- •Evidence of a progressive deteriorating medical condition that may lead to child's death during the time frame of the study
- •Medical contraindication to cochlear implantation
- •Significant visual loss
- •Autism spectrum disorder
研究组 & 干预措施
Developmentally delayed - Hearing aids
This arm contains deaf children that have developmental delays and are randomized to be treated with the conventional therapy, hearing aids.
干预措施: hearing aids (Device)
Developmentally Delayed - Cochlear implant
This arm contains deaf children that have developmental delays and are randomized to be treated with cochlear implantation.
干预措施: cochlear implantation (Device)
Not developmentally delayed
This control arm contains deaf children that do not have developmental delays and will be treated with cochlear implantation.
干预措施: cochlear implantation (Device)
结局指标
主要结局
auditory development
时间窗: two years
Linguistic development
时间窗: 2 years
Cognitive development
时间窗: 2 years
次要结局
- Quality of life(two years)
研究者
John S. Oghalai
Principle Investigator
Stanford University