At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
In Brief
A Phase 1 clinical trial evaluating cochlear implantation and hearing aids for Deafness and Hearing Loss. Completed, enrolled 303 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
This is the experimental therapy for deaf children with developmental delays, and the conventional therapy for deaf children without developmental delays.
This is the conventional therapy for deaf children with developmental delays.