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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04216475
Enrollment
10
Registered
2004-09-30
Start date
2002-10-22
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear implants Ear, Nose and Throat Conductive and sensorineural hearing loss

Interventions

Patients are going to be randomised to either intraoperative neural response telemetry (NRT) or initial fitting based on behavioural assessment.

Sponsors

Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged <4 years of age with congenital deafness and no cochlear malformations such as dysplasia. Minimum of 10 children.

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026