Outcomes In Children With Developmental Delay And Deafness
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Deafness Hearing Loss |
Device: cochlear implantation Device: hearing aids |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL |
- auditory development [ Time Frame: two years ] [ Designated as safety issue: No ]
- Linguistic development [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Cognitive development [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 252 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Device: hearing aids
This is the conventional therapy for deaf children with developmental delays.
|
|
Experimental: Developmentally Delayed - Cochlear implant
This arm contains deaf children that have developmental delays and are randomized to be treated with cochlear implantation.
|
Device: cochlear implantation
This is the experimental therapy for deaf children with developmental delays, and the conventional therapy for deaf children without developmental delays.
|
|
Active Comparator: Not developmentally delayed
This control arm contains deaf children that do not have developmental delays and will be treated with cochlear implantation.
|
Device: cochlear implantation
This is the experimental therapy for deaf children with developmental delays, and the conventional therapy for deaf children without developmental delays.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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
Contacts and Locations| Contact: John Oghalai, MD | (650) 725-6500 | joghalai@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: John Oghalai, MD 650-725-6500 joghalai@stanford.edu | |
| Principal Investigator: John Oghalai | |
| Sub-Investigator: Heidi M. Feldman | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jerry Lin, MD 713-798-3200 jwlin@bcm.tmc.edu | |
| Sub-Investigator: Jerry Lin | |
| Principal Investigator: | John Oghalai | Stanford University |
More Information
Additional Information:
Publications:
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01256229 History of Changes |
| Other Study ID Numbers: | R01DC010075, R01DC010075, eProtocol #19249 |
| Study First Received: | November 12, 2010 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stanford University:
|
deafness hearing loss developmental delay mental retardation |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013