HIV InfectionsNEUROPSY-HEUNCT04108728
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
A study testing BRIEF SCORE AT INCLUSION in people with HIV Infections and Exposure During Pregnancy, run by Nantes University Hospital at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality
- What is being tested?
- BRIEF SCORE AT INCLUSION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Nov 2019to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- great prematurity (28-32 weeks)
- genetic anomaly
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
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.
Read the 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).
- Conditions
- HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction
- Being tested
- BRIEF SCORE AT INCLUSION
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIEF SCORE AT INCLUSIONDiagnostic test
BRIEF SCALE evaluation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: BRIEF SCORE AT INCLUSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the executive function of children HEU
Behaviour rating inventary of executive function (BRIEF) preschool version score
Measured: inclusion
Secondary outcomes (4)
Intellectual quotient
Wechsler tests score
Measured: at INCLUSION, 12 months after inclusion, 24 months after inclusion
functional development
age and stage questionnaires score
Measured: at INCLUSION, 12 months after inclusion, 24 months after inclusion
behaviour
Strengths and Difficulties Questionnaire score
Measured: at INCLUSION, 12 months after inclusion, 24 months after inclusion
language
language dysfunction scale score
Measured: 12 months after inclusion,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start19 Nov 2019
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108728
- Sponsor's protocol ID
- RC19_0052
- Acronym
- NEUROPSY-HEU
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
- ClinicalTrials.gov ID
- NCT04108728
- Acronym / sponsor ID
- NEUROPSY-HEU / RC19_0052
- Conditions
- HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV exposed children during pregnancy | Experimental | Diagnostic Test: BRIEF SCORE AT INCLUSIONchildren 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 | Other | Diagnostic Test: BRIEF SCORE AT INCLUSIONchildren, 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. |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- experimental:
- control:
Key exclusion criteria (2 listed)
- great prematurity (28-32 weeks)
- genetic anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIEF SCORE AT INCLUSIONBRIEF SCALE evaluation | Diagnostic test | HIV exposed children during pregnancy, control children |
Primary outcome
evaluate the executive function of children HEU
Time frame: inclusion
Behaviour rating inventary of executive function (BRIEF) preschool version score
4 secondary outcomes
Intellectual quotient
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
functional development
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
behaviour
Time frame: at INCLUSION, 12 months after inclusion, 24 months after inclusion
language
Time frame: 12 months after inclusion,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIEF SCORE AT INCLUSION in people with HIV Infections and Exposure During Pregnancy, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the executive function of children HEU (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.