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Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

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ClinicalTrials.gov Identifier: NCT00960102
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
University of Eastern Finland
Hospital District of Helsinki and Uusimaa
Helsinki University
Oulu University Hospital
University of Oulu
Turku University Hospital
Tampere University Hospital
Information provided by (Responsible Party):
Heikki Lopponen, Kuopio University Hospital

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date August 9, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Assessment of auditory performance skills of bilaterally or bimodally implanted children or children with bilateral hearing aids [ Time Frame: Various time points up to 5 years hearing age ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
Assessment of auditory performance skills of bilaterally or unilaterally implanted children [ Time Frame: Various time points up to 5 years hearing age ]
Change History Complete list of historical versions of study NCT00960102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
  • To compare post-operative speech perception ability, language acquisition, and speech production [ Time Frame: Various time points up to 5 years hearing age ]
  • To compare speech recognition performance [ Time Frame: Various time points up to 5 years hearing age ]
  • Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate the differences in balance function [ Time Frame: at 3 and 5 year age ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • To compare post-operative speech perception ability, language acquisition, and speech production over time between children with bilateral cochlear implants and children with unilateral cochlear implant and hearing aid [ Time Frame: Various time points up to 5 years hearing age ]
  • To compare speech recognition performance of bilaterally implanted subjects to unilaterally implanted subjects [ Time Frame: Various time points up to 5 years hearing age ]
  • Quality of life and functional communicative performance assessed by parental proxy measures, and health economical assessment [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ]
  • To evaluate the differences in balance function between children with bilateral cochlear implant surgery compared to children with unilateral cochlear implant surgery [ Time Frame: at 3 and 5 year age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Children's Bilateral Cochlear Implantation in Finland
Official Title  ICMJE Children's Bilateral Cochlear Implantation in Finland: a Prospective, Controlled, Multicenter Study
Brief Summary The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation in Finnish children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Deafness
  • Hearing Loss
Intervention  ICMJE
  • Device: cochlear implant
    Multichannel Nucleus cochlear implant
  • Device: hearing aid
    Phonak Valeo hearing aid
Study Arms  ICMJE
  • Active Comparator: bilateral cochlear implant
    Intervention: Device: cochlear implant
  • Active Comparator: cochlear implant and hearing aid
    Interventions:
    • Device: cochlear implant
    • Device: hearing aid
  • Active Comparator: bilateral hearing aid
    Intervention: Device: hearing aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 7, 2018
Actual Primary Completion Date August 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Congenital severe or profound bilateral hearing impairment
  • No functional benefit from conventional hearing aids (minimum 3 months trial)
  • Radiologically (CT,MRI) patent inner ears and normal central auditory pathways
  • Family is motivated for rehabilitation programme and gives a written consent
  • Finnish or Swedish as the primary language in the home

Exclusion Criteria:

  • A child has an additional anomaly or disability that may affect to his/her functional or neurological development
  • Inner ear anomaly
  • Mother's pregnancy duration less than 32 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960102
Other Study ID Numbers  ICMJE KUH5551819
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heikki Lopponen, Kuopio University Hospital
Study Sponsor  ICMJE Kuopio University Hospital
Collaborators  ICMJE
  • University of Eastern Finland
  • Hospital District of Helsinki and Uusimaa
  • Helsinki University
  • Oulu University Hospital
  • University of Oulu
  • Turku University Hospital
  • Tampere University Hospital
Investigators  ICMJE
Study Director: Heikki J Löppönen, M.D.,Prof. Department of Otorhinolaryngology, Institute of Clinical Medicine, Kuopio University and Kuopio University Hospital, Finland
Principal Investigator: Taina T Välimaa, Ph.D. Faculty of Humanities, Logopedics, University of Oulu, Finland
PRS Account Kuopio University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP