Executive Dysfunction, Exposure During Pregnancy, HIV Infections, Neurophysiologic Abnormality
Conditions
Brief summary
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
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).
Interventions
DIAGNOSTIC_TESTBRIEF SCORE AT INCLUSION
BRIEF SCALE evaluation
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 3 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the executive function of children HEU | inclusion | Behaviour rating inventary of executive function (BRIEF) preschool version score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intellectual quotient | at INCLUSION, 12 months after inclusion, 24 months after inclusion | Wechsler tests score |
| functional development | at INCLUSION, 12 months after inclusion, 24 months after inclusion | age and stage questionnaires score |
| behaviour | at INCLUSION, 12 months after inclusion, 24 months after inclusion | Strengths and Difficulties Questionnaire score |
| language | 12 months after inclusion, | language dysfunction scale score |
Countries
France
Outcome results
None listed