Outcomes In Children With Developmental Delay And Deafness

NCT01256229 | Completed Phase 1

• 2 other identifiers: R01DC010075eProtocol #19249
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 2

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.

Conditions

Deafness; Hearing Loss

Keywords

deafness; hearing loss; developmental delay; mental retardation

Outcome Measures

Primary Outcomes (3)

• auditory development

  two years

• Linguistic development

  2 years

• Cognitive development

  2 years

Secondary Outcomes (1)

• Quality of life

  two years

Study Arms (3)

Developmentally delayed - Hearing aids

EXPERIMENTAL

This arm contains deaf children that have developmental delays and are randomized to be treated with the conventional therapy, hearing aids.

Device: hearing aids

Developmentally Delayed - Cochlear implant

EXPERIMENTAL

This arm contains deaf children that have developmental delays and are randomized to be treated with cochlear implantation.

Device: cochlear implantation

Not developmentally delayed

ACTIVE COMPARATOR

This control arm contains deaf children that do not have developmental delays and will be treated with cochlear implantation.

Device: cochlear implantation

Interventions

cochlear implantation DEVICE

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

Developmentally Delayed - Cochlear implant; Not developmentally delayed

hearing aids DEVICE

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

Developmentally delayed - Hearing aids

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Baylor College of Medicine: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (10)

• Sevy AB, Bortfeld H, Huppert TJ, Beauchamp MS, Tonini RE, Oghalai JS. Neuroimaging with near-infrared spectroscopy demonstrates speech-evoked activity in the auditory cortex of deaf children following cochlear implantation. Hear Res. 2010 Dec 1;270(1-2):39-47. doi: 10.1016/j.heares.2010.09.010. Epub 2010 Oct 1.

  PMID: 20888894 BACKGROUND

• Lin JW, Mody A, Tonini R, Emery C, Haymond J, Vrabec JT, Oghalai JS. Characteristics of malfunctioning channels in pediatric cochlear implants. Laryngoscope. 2010 Feb;120(2):399-404. doi: 10.1002/lary.20668.

  PMID: 19950369 BACKGROUND

• Katzenstein JM, Oghalai JS, Tonini R, Baker D, Haymond J, Caudle SE. Neurocognitive functioning of a child with partial trisomy 6 and monosomy 21. Neurocase. 2009;15(2):97-100. doi: 10.1080/13554790802631910. Epub 2009 Jan 26.

  PMID: 19172430 BACKGROUND

• Cristobal R, Oghalai JS. Hearing loss in children with very low birth weight: current review of epidemiology and pathophysiology. Arch Dis Child Fetal Neonatal Ed. 2008 Nov;93(6):F462-8. doi: 10.1136/adc.2007.124214.

  PMID: 18941031 BACKGROUND

• Oghalai JS, Tonini R, Rasmus J, Emery C, Manolidis S, Vrabec JT, Haymond J. Intra-operative monitoring of cochlear function during cochlear implantation. Cochlear Implants Int. 2009 Mar;10(1):1-18. doi: 10.1002/cii.372.

  PMID: 18937280 BACKGROUND

• Pierson SK, Caudle SE, Krull KR, Haymond J, Tonini R, Oghalai JS. Cognition in children with sensorineural hearing loss: etiologic considerations. Laryngoscope. 2007 Sep;117(9):1661-5. doi: 10.1097/MLG.0b013e3180ca7834.

  PMID: 17690618 BACKGROUND

• Kushalnagar P, Krull K, Hannay J, Mehta P, Caudle S, Oghalai J. Intelligence, parental depression, and behavior adaptability in deaf children being considered for cochlear implantation. J Deaf Stud Deaf Educ. 2007 Summer;12(3):335-49. doi: 10.1093/deafed/enm006. Epub 2007 Apr 21.

  PMID: 17449899 BACKGROUND

• Choi CH, Oghalai JS. Predicting the effect of post-implant cochlear fibrosis on residual hearing. Hear Res. 2005 Jul;205(1-2):193-200. doi: 10.1016/j.heares.2005.03.018.

  PMID: 15953528 BACKGROUND

• Oghalai JS, Chen L, Brennan ML, Tonini R, Manolidis S. Neonatal hearing loss in the indigent. Laryngoscope. 2002 Feb;112(2):281-6. doi: 10.1097/00005537-200202000-00015.

  PMID: 11889384 BACKGROUND

• Oghalai JS, Bortfeld H, Feldman HM, Chimalakonda N, Emery C, Choi JS, Zhou S. Cochlear Implants for Deaf Children With Early Developmental Impairment. Pediatrics. 2022 Jun 1;149(6):e2021055459. doi: 10.1542/peds.2021-055459.

  PMID: 35607935 DERIVED

MeSH Terms

Conditions

Deafness; Hearing Loss; Learning Disabilities; Intellectual Disability

Interventions

Cochlear Implantation; Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• John Oghalai

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: December 8, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (2)