Evaluation of initial fitting of young children using intraoperative neural response telemetry (NRT)
| ISRCTN | ISRCTN04216475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04216475 |
| Secondary identifying numbers | N0045122960 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Justine Maggs
Scientific
Scientific
Birmingham Children's Cochlear Implant Programme
Vision Sciences Building
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of initial fitting of young children using intraoperative neural response telemetry (NRT) |
| Study objectives | How do the two existing methods of mapping cochlear implants, intraoperative neural response telemetry measures and behavioural assessment compare? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 22/10/2002 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | Children aged <4 years of age with congenital deafness and no cochlear malformations such as dysplasia. Minimum of 10 children. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 22/10/2002 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aston University
Birmingham
B4 7ET
United Kingdom
B4 7ET
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Birmingham Children's Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
