Bilateral Cochlear Implantation in Children. The Simbici project, providing evidence

Bilateral Cochlear Implantation in Children. The Simbici project, providing evidence - The Simbici project

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35277

Enrollment

Registered

2011-10-13

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

deafness sensorineural hearing loss

Interventions

Uni- en bilateral cochlear implantation.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: * age at implantation of the children of the studygroup (simultaneous, or short interval sequential cochlear implantation) and of the controlgroup (unilateral cochlear implantation) below 2 years * similar system implanted in both studygroup and control group, complete insertion of the electrode * normal hearing parents

Exclusion criteria

Exclusion criteria: * multilinguality * developmental delay, learning or behavioural problems

Design outcomes

Primary

Measure	Time frame
All children that receive cochlear implants in the Netherlands, either bilateral or unilateral, are evaluated pre-implantation and following implantation with performance tests like for instance speech recognition, and with the use of parent-proxy questionnaires. This is needed to provide the best possible care in selecting candidates, and ensuring optimal rehabilitation and aftercare for these children. For the Simbici project only a limited number of tests and parent(teacher)-proxy questionnaire are added to the regular cochlear implant program. these are shown below (primary and secundary outcome measures). The primary and secondary outcome measures agree with those used in the retrospective multicenter Simbici study in The Netherlands (CMO 2010/248). Primary outcome measures Simbici project Verbal memory and reasoning: • (Auditive) memory (Kaufmann-II) • Verbal intelligence (WPPSI-III-NL)	—

Measure

Time frame

All children that receive cochlear implants in the Netherlands, either bilateral or unilateral, are evaluated pre-implantation and following implantation with performance tests like for instance speech recognition, and with the use of parent-proxy questionnaires. This is needed to provide the best possible care in selecting candidates, and ensuring optimal rehabilitation and aftercare for these children. For the Simbici project only a limited number of tests and parent(teacher)-proxy questionnaire are added to the regular cochlear implant program. these are shown below (primary and secundary outcome measures). The primary and secondary outcome measures agree with those used in the retrospective multicenter Simbici study in The Netherlands (CMO 2010/248). Primary outcome measures Simbici project Verbal memory and reasoning: • (Auditive) memory (Kaufmann-II) • Verbal intelligence (WPPSI-III-NL)

—

Secondary

Measure	Time frame
Secundary outcome measures Simbici project; • Speech recognition in noise test (AAST) • Phonemic development (Aarnoutse) • Narrative abilities (Bus Story test) • Psychosocial development: Child Behaviour Checklist (CBCL), Teacher Report Form (TRF) • Socio-emotional development; Theory of Mind test	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)