Evaluation of initial fitting of young children using intraoperative neural response telemetry (NRT)

ISRCTN	ISRCTN04216475
DOI	https://doi.org/10.1186/ISRCTN04216475
Protocol serial number	N0045122960
Sponsor	Department of Health
Funder	Birmingham Children's Hospital NHS Trust (UK)

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

Ms Justine Maggs
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2004

Participant type(s)	Patient
Age group	Child
Upper age limit	4 Years
Sex	All
Target sample size at registration	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

Aston University

Birmingham
B4 7ET
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes