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Consequences of a Maternal-fetal Chikungunya Virus Infection

NCT04909411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-01-05

No results posted yet for this study

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

  • Chikungunya Virus Infection

Interventions

OTHER

OPHTHALMOLOGICAL ASSESSMENT

assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination

OTHER

NEUROPSYCHOLOGICAL ASSESSMENT

completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Principal Investigators

  • Raphaelle SARTON, MD · CHU de La Réunion

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2021-10-12
Completion
2021-10-12

Countries

  • Reunion

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909411 on ClinicalTrials.gov