Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )

Study Overview
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Brief Summary
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Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV. Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.

Detailed Description
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The objective of the study is the exploration of executive functions (EF) and screening for neurodevelopment and learning disorders in children born to HIV-infected mothers, exposed to the virus and to antiretrovirals (ARVs). The evaluation of the executive functioning will be done by the score obtained at the preschool BRIEF for patients and control group issued from questionnaires filled by the mothers of the cases and the mothers of the controls, with matching on age, sex, level of parental education and socio-economic and cultural environment. Within the group of exposed children, factors associated with executive dysfunction including HIV infection, antiretroviral exposure, maternal socio-demographic data, sociocultural and environmental level will be investigated. Evolution of the scores between J0, M12 and M24 will be compared within the group of exposed children. Compared with a control group, the child's intelligence quotient, overall development, behavior and language will be compared at each follow-up time (D0, M12 and M24).

Official Title
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Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers

Conditions
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HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction

Intervention / Treatment
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* Diagnostic Test: BRIEF SCORE AT INCLUSION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: experimental: HIV-positive children born to mothers living with HIV antiretrovirals during pregnancy and in the neonatal period, aged 3 years +/- 3 months on the date of inclusion. Parents mastering the French. control: children, aged 3 years +/- 3 months on the date of inclusion, from the same socio-economic and cultural environment, no infected or affected by HIV. Parents mastering French. Exclusion Criteria: great prematurity (28-32 weeks) genetic anomaly

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV exposed children during pregnancy<br>children born from HIV-infected mother, exposed to antiretroviral drugs during pregnancy and in the neonatal period; aged 3 years-old +/- 3 months on the date of inclusion. Parents mastering french language | Diagnostic Test: BRIEF SCORE AT INCLUSION<br>* BRIEF SCALE evaluation<br>|
| Other: control children<br>children, aged 3 years +/- 3 months on the date of inclusion, from the same socio-economic and cultural environment, not infected or affected by HIV. Parents mastering French language. | Diagnostic Test: BRIEF SCORE AT INCLUSION<br>* BRIEF SCALE evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the executive function of children HEU | Behaviour rating inventary of executive function (BRIEF) preschool version score | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intellectual quotient | Wechsler tests score | at INCLUSION, 12 months after inclusion, 24 months after inclusion | 
| functional development | age and stage questionnaires score | at INCLUSION, 12 months after inclusion, 24 months after inclusion | 
| behaviour | Strengths and Difficulties Questionnaire score | at INCLUSION, 12 months after inclusion, 24 months after inclusion | 
| language | language dysfunction scale score | 12 months after inclusion, |