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Outcomes In Children With Developmental Delay And Deafness
Not Recruiting
Trial ID: NCT01256229
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.
Official Title
OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
Stanford Investigator(s)
Eligibility
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
Intervention(s):
device: cochlear implantation
device: hearing aids
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
John Oghalai, MD
650-725-6500