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Outcomes In Children With Developmental Delay And Deafness

NCT01256229 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

cochlear implantation

This is the experimental therapy for deaf children with developmental delays, and the conventional therapy for deaf children without developmental delays.

DEVICE

hearing aids

This is the conventional therapy for deaf children with developmental delays.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Baylor College of Medicine

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • John Oghalai · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256229 on ClinicalTrials.gov