Condition category
Ear, Nose and Throat
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Justine Maggs

ORCID ID

Contact details

Birmingham Children's Cochlear Implant Programme
Vision Sciences Building
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes