Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
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).
Study Design
Conditions
HIV Infections
Intervention
BRIEF SCORE AT INCLUSION
Location
Chu Angers
Angers
France
Status
Not yet recruiting
Source
Nantes University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04108728
- ClinicalTrials.gov processed this data on October 02, 2019
Published on BioPortfolio: 2019-10-03T07:54:38-0400
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Medical and Biotech [MESH] Definitions
Apgar Score
A method, developed by Dr. Virginia Apgar, to evaluate a newborn's adjustment to extrauterine life. Five items - heart rate, respiratory effort, muscle tone, reflex irritability, and color - are evaluated 60 seconds after birth and again five minutes later on a scale from 0-2, 0 being the lowest, 2 being normal. The five numbers are added for the Apgar score. A score of 0-3 represents severe distress, 4-7 indicates moderate distress, and a score of 7-10 predicts an absence of difficulty in adjusting to extrauterine life.
Injury Severity Score
An anatomic severity scale based on the Abbreviated Injury Scale (AIS) and developed specifically to score multiple traumatic injuries. It has been used as a predictor of mortality.
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Meningitis, Viral
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
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