Clinical trial NCT02539901: Development of a Deaf Child With a Cochlear Implant.
Official title: Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Keywords: cochlear implant
Developmental Psychology
cognitive development
communicative development
perceptual development
deaf child
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young patients consulting in the Unit of Pediatric Cochlear Implantation, Hospital-University Centre of Toulouse.

The normal hearing participants will be recruited by posters, produced in various places childcare (crèches, schools) or pediatric services Purpan hospital.

Brief summary: Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.

The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:

* The psychomotor and cognitive development assessed using the Brunet-Lézine test;
* The development of preverbal communication, evaluated using the Early Social Communication Scale.


Eligibility criteria: INCLUSION CRITERIA:

To achieve this study, two cohorts will be formed:

* A cohort of deaf children aged 12 to 30 months:

  * Be reached a bilateral profound sensorineural hearing loss (greater than 90 dB hearing loss, as classified by the International Bureau for Audiophonology, 1997);
  * Raise a cochlear implant;
  * Being affiliated to a social security scheme.
  * Consent representatives of parental authority (or at least one of the two)
* A cohort of deaf children from 6 to 9 years:

  * Be reached a bilateral profound sensorineural hearing loss;
  * Be holder of a cochlear implant for at least 3 years;
  * Consent representatives of parental authority (or at least one of the two).
* A group of normal hearing typically developing children:

this group will provide benchmarks for perception tests. It consists of two sub-groups:

* Children with normal hearing typically developing 12 to 30 months; children whith a general, linguistic and normal psychomotor evaluated on the basis of prior clinical examination at baseline and on the compilation of their health record. They must not present psychomotor retardation or language.
* Children with normal hearing in typical development 6 to 9 years.

  * Be matched in age and sex with deaf children (a pairing with a child on the criteria defined above). In terms of developmental age, we can consider as having comparable in terms of age development of children with:
  * +/- 6 months for the population of children 6 to 9 years
  * +/- 1 month for the population of children 12 to 30 months.
  * Have a typical development, evaluated by a grade level for their age;
  * Consent representatives of parental authority (or at least one of the two).

EXCLUSION CRITERIA:

Will be excluded from our study subjects where there is an inability to meet the tests, either in situations:

* Impossible to understand instructions
* Blindness
* Impossible to meet the tests
* Multihandicap
* A legal impossibility. Furthermore, children will be excluded for which there is a refusal on the part of the parents or of the child to participate in the study (for children old enough to express their opinion).

Primary outcomes:
measure: screening and diagnosis of global developmental delays in young children
timeFrame: inclusion
measure: evaluation of variation pre-linguistic communication and lexicon emergence
timeFrame: inclusion, 6 months, 12 months and 18 months
Secondary outcomes:
measure: Non-linguistic variation of sounds Detection Test
timeFrame: inclusion, 6 months, 12 months and 18 months
measure: Neuropsychological assessment of child development variation
timeFrame: inclusion, 6 months, 12 months and 18 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)
state: Haute-Garonne
Study officials:
affiliation: Service ORL - Hôpital Purpan
name: Olivier DEGUINE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: