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

Not Applicable

Completed

• Conditions: HIV Infections; Exposure During Pregnancy; Neurophysiologic Abnormality; Executive Dysfunction
• Interventions: Diagnostic Test: BRIEF SCORE AT INCLUSION

• Registration Number: NCT04108728
• Lead Sponsor: Nantes University Hospital

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).

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2019-11-19
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV exposed children during pregnancy	BRIEF SCORE AT INCLUSION	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
control children	BRIEF SCORE AT INCLUSION	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.

Primary Outcome Measures

Name	Time	Method
evaluate the executive function of children HEU	inclusion	Behaviour rating inventary of executive function (BRIEF) preschool version score

Secondary Outcome Measures

Name	Time	Method
behaviour	at INCLUSION, 12 months after inclusion, 24 months after inclusion	Strengths and Difficulties Questionnaire score
functional development	at INCLUSION, 12 months after inclusion, 24 months after inclusion	age and stage questionnaires score
Intellectual quotient	at INCLUSION, 12 months after inclusion, 24 months after inclusion	Wechsler tests score
language	12 months after inclusion,	language dysfunction scale score

Trial Locations

Locations (3)

Chu Angers; 🇫🇷 Angers, France

Chd Vendee; 🇫🇷 La Roche-sur-Yon, France

Chu de Nantes; 🇫🇷 Nantes, France