Children's Bilateral Cochlear Implantation in Finland (FinBiCI)

This study is currently recruiting participants.

Verified February 2013 by Kuopio University Hospital

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

ClinicalTrials.gov Identifier:

NCT00960102

First received: August 14, 2009

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 14, 2009

Last Updated Date

February 15, 2013

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

June 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of auditory performance skills of bilaterally or unilaterally implanted children [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00960102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
To compare speech recognition performance of bilaterally implanted subjects to unilaterally implanted subjects [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To evaluate operative and post-operative complications, side-effects and device failures [ Time Frame: Various time points up to 5 years hearing age ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

Active Comparator: bilateral cochlear implant
Intervention: Device: cochlear implant
Active Comparator: cochlear implant and hearing aid
Interventions:
- Device: cochlear implant
- 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2017

Estimated Primary Completion Date

June 2015 (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

Gender

Both

Ages

up to 24 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Heikki J Löppönen, M.D.,Prof.	+35817172508	heikki.lopponen@kuh.fi
Contact: Taina T Välimaa, Ph.D.	+3588553 3396	taina.valimaa@oulu.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00960102

Other Study ID Numbers ^ICMJE

KUH5551819

Has Data Monitoring Committee

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

Information Provided By

Kuopio University Hospital

Verification Date

February 2013

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

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