Trial Search Results

Outcomes In Children With Developmental Delay And Deafness

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Baylor College of Medicine

Stanford Investigator(s):

Intervention(s):

  • Device: cochlear implantation
  • Device: hearing aids

Phase:

Phase 1

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

Ages Eligible for Study

N/A - 5 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
John Oghalai, MD
650-725-6500
Recruiting