BRIEF SCORE AT INCLUSION
Diagnostic TestBRIEF SCALE evaluation
NCT Number: NCT04108728
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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Notify Me3 year–3 year
All sexes
Interventional
Not applicable
Chu Angers, Angers, France
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BRIEF SCALE evaluation
Time frame: inclusion
Behaviour rating inventary of executive function (BRIEF) preschool version score
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
Wechsler tests score
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
age and stage questionnaires score
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
Strengths and Difficulties Questionnaire score
Time frame: 12 months after inclusion,
language dysfunction scale score
Nantes University Hospital
Other
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
Acronym: NEUROPSY-HEU
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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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