Trial record 3 of 484 for:    Deafness

Outcomes In Children With Developmental Delay And Deafness

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Stanford University
Sponsor:
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01256229
First received: November 12, 2010
Last updated: February 8, 2013
Last verified: February 2013
  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.


Condition Intervention Phase
Deafness
Hearing Loss
Device: cochlear implantation
Device: hearing aids
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OUTCOMES IN CHILDREN WITH DEVELOPMENTAL DELAY AND DEAFNESS: A PROSPECTIVE, RANDOMIZED TRIAL

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • auditory development [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Linguistic development [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cognitive development [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: September 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256229

Contacts
Contact: John Oghalai, MD (650) 725-6500 joghalai@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: John Oghalai, MD    650-725-6500    joghalai@stanford.edu   
Principal Investigator: John Oghalai         
Sub-Investigator: Heidi M. Feldman         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jerry Lin, MD    713-798-3200    jwlin@bcm.tmc.edu   
Sub-Investigator: Jerry Lin         
Sponsors and Collaborators
Stanford University
Baylor College of Medicine
Investigators
Principal Investigator: John Oghalai Stanford University
  More Information

Additional Information:
Publications:

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01256229     History of Changes
Other Study ID Numbers: R01DC010075, R01DC010075, eProtocol #19249
Study First Received: November 12, 2010
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
deafness
hearing loss
developmental delay
mental retardation

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

ClinicalTrials.gov processed this record on July 29, 2014