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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Neurophysiologic Abnormality; HIV Infections; Executive Dysfunction; Exposure During Pregnancy

Treatments: Diagnostic Test: BRIEF SCORE AT INCLUSION

Study type: Interventional

Funder types: Other

Identifiers

NCT04108728

RC19_0052

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 3 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

HIV exposed children during pregnancy

Experimental group

Description:

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

Treatment:

Diagnostic Test: BRIEF SCORE AT INCLUSION

control children

Other group

Description:

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.

Treatment:

Diagnostic Test: BRIEF SCORE AT INCLUSION