Trials / Completed
CompletedNCT04108728
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 3 Years – 3 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | BRIEF SCORE AT INCLUSION | BRIEF SCALE evaluation |
Timeline
- Start date
- 2019-11-19
- Primary completion
- 2024-03-05
- Completion
- 2024-03-05
- First posted
- 2019-09-30
- Last updated
- 2024-07-30
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04108728. Inclusion in this directory is not an endorsement.