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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06841900




Registration number
NCT06841900
Ethics application status
Date submitted
17/02/2025
Date registered
24/02/2025

Titles & IDs
Public title
Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients
Scientific title
Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study
Secondary ID [1] 0 0
ICF in Paediatric CI users
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cochlear Impant Children 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Cochlear Implantation

Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss - Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss


Treatment: Devices: Cochlear Implantation
Standard cochlear implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in LittlEARS® Auditory Questionnaire (LEAQ)
Timepoint [1] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [2] 0 0
Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P)
Timepoint [2] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [3] 0 0
Change in Speech Intelligibility Rating (SIR)
Timepoint [3] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [4] 0 0
Parent's Evaluation of Aural/Oral Performance of Children (PEACH)
Timepoint [4] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [5] 0 0
Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry
Timepoint [5] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [6] 0 0
Auditory Brainstem Response (ABR) Audiometry
Timepoint [6] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Primary outcome [7] 0 0
Ling Sounds (detection/discrimination)
Timepoint [7] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Secondary outcome [1] 0 0
Subject Demographics
Timepoint [1] 0 0
1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

Eligibility
Key inclusion criteria
General

* Children aged < 18 years with prelingual bilateral severe-to-profound HL
* Signed and dated informed consent, informed permission and/or minor's assent.
* Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
* Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.

Audiological

* Completion of hearing assessment battery showing suitability of the CI candidates.
* Compliance with cochlear implant candidate selection criteria of the implanting centre.
* First cochlear implantation Medical
* Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General

* Re-implantation of the cochlear implant
* No motivation to participate in the study and/or unreasonable expectations. Medical
* Presence of contra-indications for surgery in general and cochlear implantation in particular.
* Presence of central auditory lesions.
* Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
* Compressed
* Split
* Any type of custom made electrodes

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Fremantle Hospital Group - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Edegem
Country [2] 0 0
Germany
State/province [2] 0 0
Würzburg
Country [3] 0 0
Poland
State/province [3] 0 0
Warsaw
Country [4] 0 0
Saudi Arabia
State/province [4] 0 0
Riyadh
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Antwerp
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ellen Andries, PhD AUD
Address 0 0
Country 0 0
Phone 0 0
+32 3 275 7372
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06841900