Clinical trial NCT04108728: Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
Official title: Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Exposure During Pregnancy
Neurophysiologic Abnormality
Executive Dysfunction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: evaluate the executive function of children HEU
timeFrame: inclusion
Secondary outcomes:
measure: Intellectual quotient
timeFrame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
measure: functional development
timeFrame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
measure: behaviour
timeFrame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
measure: language
timeFrame: 12 months after inclusion,
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
References: