Status:
COMPLETED
Outcomes In Children With Developmental Delay And Deafness
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Baylor College of Medicine
Conditions:
Deafness
Hearing Loss
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
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...
Detailed Description
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 criter...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01256229
Start Date
September 1 2009
End Date
September 1 2016
Last Update
November 15 2016
Active Locations (2)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Baylor College of Medicine
Houston, Texas, United States, 77030