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

Primary Purpose

HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BRIEF SCORE AT INCLUSION
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections

Eligibility Criteria

3 Years - 3 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Angers
  • Chd Vendee
  • Chu de Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HIV exposed children during pregnancy

control children

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intellectual quotient
Wechsler tests score
functional development
age and stage questionnaires score
behaviour
Strengths and Difficulties Questionnaire score
language
language dysfunction scale score

Full Information

First Posted
September 26, 2019
Last Updated
August 25, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04108728
Brief Title
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
Acronym
NEUROPSY-HEU
Official Title
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV exposed children during pregnancy
Arm Type
Experimental
Arm Description
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
Arm Title
control children
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
BRIEF SCORE AT INCLUSION
Intervention Description
BRIEF SCALE evaluation
Primary Outcome Measure Information:
Title
evaluate the executive function of children HEU
Description
Behaviour rating inventary of executive function (BRIEF) preschool version score
Time Frame
inclusion
Secondary Outcome Measure Information:
Title
Intellectual quotient
Description
Wechsler tests score
Time Frame
at INCLUSION, 12 months after inclusion, 24 months after inclusion
Title
functional development
Description
age and stage questionnaires score
Time Frame
at INCLUSION, 12 months after inclusion, 24 months after inclusion
Title
behaviour
Description
Strengths and Difficulties Questionnaire score
Time Frame
at INCLUSION, 12 months after inclusion, 24 months after inclusion
Title
language
Description
language dysfunction scale score
Time Frame
12 months after inclusion,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Angers
City
Angers
Country
France
Facility Name
Chd Vendee
City
La Roche-sur-Yon
Country
France
Facility Name
Chu de Nantes
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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