Clinical Trials Directory

Trials / Completed

CompletedNCT04909411

Consequences of a Maternal-fetal Chikungunya Virus Infection

Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Centre Hospitalier Universitaire de la Réunion · Academic / Other
Sex
All
Age
10 Years – 16 Years
Healthy volunteers
Accepted

Summary

Chikungunya is an infectious disease caused by an alphavirus transmitted by the Aedes mosquitoes which has known a worldwide expansion since its re-emergence in 2004. Regarding to an unprecedented epidemic, Reunionese pediatricians described in 2005-2006 a vertical maternal-fetal transmission of this virus, at the time of childbirth. Since then, this mode of transmission has been widely confirmed, with an absolute risk estimated between 15.5% and 48.3%. The main consequences for the child are neuromotor, neurosensory or neurocognitive. They were studied around the age of 2 in 33 children in the CHIMERE cohort, as well as at the age of 5 in a small fraction of these children followed at the C.A.M.S.P (Center for Early Medico-Social Action). The results suggested an overall delay in psychomotor acquisitions secondary to neonatal infection, affecting the functions of the prefrontal region (in particular coordination and language). Performance was correlated with the severity of the clinical presentation (more severe in case of encephalitis or encephalopathy) while remaining suboptimal in children with uncomplicated infection. During neurodevelopmental monitoring, other disturbing traits complemented the spectrum of problems presented by these children, such as microcephaly, cerebral palsy, epilepsy, interaction disorder or attention deficit disorder. At around age 10, the investigators reassessed 21 of these children using the Childhood Cognitive Function and Learning (EDA) screening test. The investigators would now like to confirm and characterize their impairments using a battery of confirmatory tests around the age of 13.

Conditions

Interventions

TypeNameDescription
OTHEROPHTHALMOLOGICAL ASSESSMENTassessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination
OTHERNEUROPSYCHOLOGICAL ASSESSMENTcompletion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire

Timeline

Start date
2020-01-13
Primary completion
2021-10-12
Completion
2021-10-12
First posted
2021-06-01
Last updated
2024-01-05

Locations

1 site across 1 country: Reunion

Source: ClinicalTrials.gov record NCT04909411. Inclusion in this directory is not an endorsement.