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

HIV Infections Clinical Trial

— NEUROPSY-HEU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04108728
• Other study ID #: RC19_0052
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: May 5, 2024

Study information

• Verified date: August 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: May 5, 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 3 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• BRIEF SCORE AT INCLUSION
BRIEF SCALE evaluation

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Chd Vendee	La Roche-sur-Yon
France	Chu de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the executive function of children HEU	Behaviour rating inventary of executive function (BRIEF) preschool version score	inclusion
Secondary	Intellectual quotient	Wechsler tests score	at INCLUSION, 12 months after inclusion, 24 months after inclusion
Secondary	functional development	age and stage questionnaires score	at INCLUSION, 12 months after inclusion, 24 months after inclusion
Secondary	behaviour	Strengths and Difficulties Questionnaire score	at INCLUSION, 12 months after inclusion, 24 months after inclusion
Secondary	language	language dysfunction scale score	12 months after inclusion,