Clinical Trial: Outcomes In Children With Developmental Delay And Deafness
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
Brief Summary:
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.
Detailed Summary:
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
Sponsor: Stanford University
Current Primary Outcome:
- auditory development [ Time Frame: two years ]
- Linguistic development [ Time Frame: 2 years ]
- Cognitive development [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Quality of life [ Time Frame: two years ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: November 12, 2010
Date Started: September 2009
Date Completion:
Last Updated: November 11, 2016
Last Verified: November 2016
