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Effects and costs of Bilateral Cochlear Implantation in Children (RCT).


- candidate number10918
- NTR NumberNTR3232
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2012
- Secondary IDsNL34845.041.10 CCMO
- Public TitleEffects and costs of Bilateral Cochlear Implantation in Children (RCT).
- Scientific TitleBilateral Cochlear Implantation in Children; A pragmatic randomised controlled trial.
- ACRONYMBICEPS
- hypothesisBilateral cochlear implantation in children has potentially an advantage over unilateral cochlear implantation in terms of communication development (both preverbal communication and language development) and sound localization. This study will compare the effects of simultaneous and sequential bilateral cochlear implantation. This not only allows to compare the effects of simultaneous and sequential bilateral cochlear implantation , but also of unilateral and bilateral cochlear implantation.
- Healt Condition(s) or Problem(s) studiedDeafness, Hearing loss
- Inclusion criteria1. Age í▄ 2 years;
2. Current clinically used cochlear implant criteria of the multidisciplinary cochlear implant team of the UMC Utrecht;
3. Willingness and ability of parents or guardians to participate in all scheduled procedures outlined in the protocol;
4. General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery;
5. Patients covered by the Dutch health insurance.
- Exclusion criteria1. Abnormal cochlear anatomy in one or both ears;
2. Chronic ear infection in one or both ears;
3. Previous implant experience;
4. Disability which could interfere with the completion of the tests;
5. Deafness caused by meningitis, otosclerosis or Cogans syndrome;
6. Severely visually impaired.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-apr-2012
- planned closingdate2-apr-2018
- Target number of participants45
- InterventionsSimultaneous or sequential bilateral cochlear implantation.
- Primary outcomePerformance on the non-looking vocal turns (NLVT) component of the Tait video analysis in the individual patientí»s best aided condition.
- Secondary outcome1. Localisation abilities assessed with the: A. Left-Right discrimination test;
B. Movement Tracking Test;
C. 3-alternative localisation test.
2. Assessment of speech perception in noise with the spatial release from masking (SRM) test;
3. Assessment of auditory pathway development with ABR and cortical auditory evoked potentials.
- Timepoints1. Preoperatively;
2. 6 months post (first) implantation;
3. 12 months post (first) implantation;
4. 24 months post (first) implantation;
5. 36 months post (first) implantation;
6. 48 months post (first) implantation.
- Trial web sitewww.biceps-studie.nl
- statusstopped
- CONTACT FOR PUBLIC QUERIESDrs. M.J.W. Lammers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Grolman
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of ENT
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThis study will investigate the benefit of bilateral cochlear implantation over unilateral cochlear implantation in children who are implanted with two cochlear implants either simultaneously or sequentially. The objective is to evaluate the degree of bilateral benefit gained from having a second implant. 45 Children with severe to profound sensorineural hearing loss will be included in this Randomised Controlled Trial. Half of the group shall receive one implant at the beginning of the study and a second implant after a period of two years. The other half shall receive two cochlear implants simultaneously during one operation. Objective and subjective parameters will be measured during evaluation sessions pre-operatively, 6, 12, 24, 36 and 48 months after the first cochlear implantation.
- Main changes (audit trail)
- RECORD12-jan-2012 - 13-jan-2016


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