Development of a Deaf Child With a Cochlear Implant.

NCT02539901 | Completed

• 2 other identifiers: 11 227 022011-A01058-33
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Keywords

cochlear implant; Developmental Psychology; cognitive development; communicative development; perceptual development; deaf child

Outcome Measures

Primary Outcomes (2)

• screening and diagnosis of global developmental delays in young children

  inclusion

• evaluation of variation pre-linguistic communication and lexicon emergence

  inclusion, 6 months, 12 months and 18 months

Secondary Outcomes (2)

• Non-linguistic variation of sounds Detection Test

  inclusion, 6 months, 12 months and 18 months

• Neuropsychological assessment of child development variation

  inclusion, 6 months, 12 months and 18 months

Study Arms (4)

12-30 months-old deaf children

Children with deafness of bilateral deep perception had : Evaluation of the detection of non-linguistic sounds, Early Social Communication Scale (ECSP) and psychomotor infancy development scale or Lézine Brunet-Revised scale

Behavioral: Evaluation of the detection of non-linguistic sounds; Behavioral: Early Social Communication Scale (ECSP); Behavioral: psychomotor infancy development scale

6-9 years-old deaf children

Free hearing test categorization and NEPSY (two domains: "memory and learning" and "attention and executive functions") in 6-9 years-old deaf child cohort with deafness of bilateral deep perception and carrying a cochlear implant

Behavioral: Free hearing test categorization; Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").

12-30 months-old normal hearing children

Evaluation of the detection of non-linguistic sounds in 12-30 months-old normal hearing child cohort

Behavioral: Evaluation of the detection of non-linguistic sounds

6-9 years-old normal hearing children

'Free hearing test categorization' in 6-9 years-old normal hearing child cohort

Behavioral: Free hearing test categorization

Interventions

Evaluation of the detection of non-linguistic sounds BEHAVIORAL

Evaluation of the detection of non-linguistic sounds (sound room)

12-30 months-old deaf children; 12-30 months-old normal hearing children

Free hearing test categorization BEHAVIORAL

Free hearing test categorization evaluation

6-9 years-old deaf children; 6-9 years-old normal hearing children

Early Social Communication Scale (ECSP) BEHAVIORAL

Early Social Communication Scale (ECSP) evaluation

12-30 months-old deaf children

psychomotor infancy development scale BEHAVIORAL

Also known as: Lézine Brunet-Revised scale

12-30 months-old deaf children

NEPSY (two domains: "memory and learning" and "attention and executive functions"). BEHAVIORAL

NEPSY evaluation

6-9 years-old deaf children

Eligibility Criteria

• Age: 12 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)

Toulouse, Haute-Garonne, 31059, France

Location

MeSH Terms

Conditions

Deafness

Interventions

Neuropsychological Tests; Educational Status

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Study Officials

• Olivier DEGUINE, MD, PhD

  Service ORL - Hôpital Purpan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 3, 2015
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 3, 2015

Record last verified: 2015-08

Locations

FR (1)