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NCT Number: NCT04108728

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRIEF SCORE AT INCLUSION

Diagnostic Test

BRIEF SCALE evaluation

Primary outcomes

  1. evaluate the executive function of children HEU

    Time frame: inclusion

    Behaviour rating inventary of executive function (BRIEF) preschool version score

Secondary outcomes

  1. Intellectual quotient

    Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion

    Wechsler tests score

  2. functional development

    Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion

    age and stage questionnaires score

  3. behaviour

    Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion

    Strengths and Difficulties Questionnaire score

  4. language

    Time frame: 12 months after inclusion,

    language dysfunction scale score

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: NEUROPSY-HEU

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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