Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045122960
Study information
Scientific title
Evaluation of initial fitting of young children using intraoperative neural response telemetry (NRT)
Acronym
Study hypothesis
How do the two existing methods of mapping cochlear implants, intraoperative neural response telemetry measures and behavioural assessment compare?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cochlear implants
Intervention
Patients are going to be randomised to either intraoperative neural response telemetry (NRT) or initial fitting based on behavioural assessment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Performance on Infant Toddler Meaningful Auditory Integrated Scale (IT-MAIS)
2. Performance on phonemes differentiation test (APE)
3. Soundfield Threshold Assessment
4. Time spent performing clinical activities involved
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/10/2002
Overall trial end date
01/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged <4 years of age with congenital deafness and no cochlear malformations such as dysplasia. Minimum of 10 children.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
10
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
22/10/2002
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aston University
Birmingham
B4 7ET
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Birmingham Children's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary