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

NCT04108728 | Completed

• 1 other identifier: RC19_0052
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; Exposure During Pregnancy; Neurophysiologic Abnormality; Executive Dysfunction

Outcome Measures

Primary Outcomes (1)

• evaluate the executive function of children HEU

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

  inclusion

Secondary Outcomes (4)

• Intellectual quotient

  at INCLUSION, 12 months after inclusion, 24 months after inclusion

• functional development

  at INCLUSION, 12 months after inclusion, 24 months after inclusion

• behaviour

  at INCLUSION, 12 months after inclusion, 24 months after inclusion

• language

  12 months after inclusion,

Study Arms (2)

HIV exposed children during pregnancy

EXPERIMENTAL

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

Diagnostic Test: BRIEF SCORE AT INCLUSION

control children

OTHER

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.

Diagnostic Test: BRIEF SCORE AT INCLUSION

Interventions

BRIEF SCORE AT INCLUSION DIAGNOSTIC_TEST

BRIEF SCALE evaluation

HIV exposed children during pregnancy; control children

Eligibility Criteria

• Age: 3 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• experimental:
• Parents mastering the French.
• control:
• Parents mastering French.

You may not qualify if:

• great prematurity (28-32 weeks)
• genetic anomaly

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

Chu Angers

Angers, France

Location

Chd Vendee

La Roche-sur-Yon, France

Location

Chu de Nantes

Nantes, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: November 19, 2019
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (3)