Development of a Deaf Child With a Cochlear Implant. (DECCODES)

Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.

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.

Study Overview

• Status: Completed
• Conditions: Deafness
• Intervention / Treatment: Behavioral: Evaluation of the detection of non-linguistic sounds; Behavioral: Early Social Communication Scale (ECSP); Behavioral: psychomotor infancy development scale; Behavioral: Free hearing test categorization; Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Evaluation of the detection of non-linguistic sounds (sound room); Behavioral: Early Social Communication Scale (ECSP); Early Social Communication Scale (ECSP) evaluation; Behavioral: psychomotor infancy development scale; Other Names: Lézine Brunet-Revised 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; Free hearing test categorization evaluation; Behavioral: NEPSY (two domains: "memory and learning" and "attention and executive functions").; NEPSY evaluation
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; Evaluation of the detection of non-linguistic sounds (sound room)
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; Free hearing test categorization evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Olivier DEGUINE, MD, PhD, Service ORL - Hôpital Purpan

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: cochlear implant; cognitive development; Developmental Psychology; communicative development; perceptual development; deaf child
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 11 227 02; 2011-A01058-33 (Registry Identifier: Agence National du Médicament et des Produits de santé)