Bilateral cochlear implantation in children; a pragmatic randomised controlled trial

Bilateral cochlear implantation in children; a pragmatic randomised controlled trial - BiCI children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36764

Enrollment

Registered

2011-04-04

Start date

2012-05-14

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Deafness Hearing loss

Interventions

Group A: bilateral simultaneous cochlear implantation Group B: bilateral sequential cochlear implantation

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Cochlear implant candidacy, according to the current criteria - Age

Exclusion criteria

Exclusion criteria: - General health not allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery. - Abnormal cochlear anatomy in one or both ears. - Chronic ear infection in one or both ears. - Previous cochlear implant experience. - Disability which could interfere with the completion of the tests. - Deafness caused by meningitis, otosclerosis or Cogans syndrome. - Severely visually impaired

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the performance on the TAIT video analysis.	—

Secondary

Measure	Time frame
Secondary outcomes will be the performance on: - soundlocalization tests - auditory perception measures - electrophysiology tests: Auditory brainstem response (ABR) and Cortical auditory evoked potentials (CAEP)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)