Outcomes In Children With Developmental Delay And Deafness
Completed · Phase 1
Conditions studied: Deafness, Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT01256229
- Run by
- Stanford University
- People needed
- 303
- Starts
- 2009-09-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-11-15
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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