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Outcomes In Children With Developmental Delay And Deafness

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ClinicalTrials.gov Identifier: NCT01256229
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : November 15, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Deafness Hearing Loss Device: cochlear implantation Device: hearing aids Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL
Study Start Date : September 2009
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. auditory development [ Time Frame: two years ]
  2. Linguistic development [ Time Frame: 2 years ]
  3. Cognitive development [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256229


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Baylor College of Medicine
Investigators
Principal Investigator: John Oghalai Stanford University
More Information

Additional Information:
Publications:

Responsible Party: John S. Oghalai, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01256229     History of Changes
Other Study ID Numbers: R01DC010075 ( U.S. NIH Grant/Contract )
eProtocol #19249
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by John S. Oghalai, Stanford University:
deafness
hearing loss
developmental delay
mental retardation

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms