Consequences of a Maternal-fetal Chikungunya Virus Infection (CHIK13+)

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

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.

Study Overview

• Status: Completed
• Conditions: Chikungunya Virus Infection
• Intervention / Treatment: Other: OPHTHALMOLOGICAL ASSESSMENT; Other: NEUROPSYCHOLOGICAL ASSESSMENT

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Réunion
  • Saint-Pierre, Réunion, 97410
    • CHU de la réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child born between March 2005 and July 2006
• Of which the mother identified in the CHIMERE cohort or the perinatal register of maternities
• Exposed: child infected with the chikungunya virus at the time of childbirth
• Not exposed: child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified in chapter 5.2
• Affiliated to a social insurance

Exclusion Criteria:

• Prematurity <33 weeks
• Prenatal alcoholization authenticated by fetal alcohol syndrome
• Intellectual disability or secondary epilepsy of origin other than CHIKV infection (caused by ACSOS or any other cause of brain damage of inflammatory, metabolic or infectious origin)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exposed arm; child infected with chikungunya virus during childbirth	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
Other: Non-exposed arm; child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intelligence quotient	Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5	Month 3 (+/- 1 month)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Raphaelle SARTON, MD, CHU de la réunion

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Disease Attributes; Arbovirus Infections; Vector Borne Diseases; Alphavirus Infections; Togaviridae Infections; Infections; Communicable Diseases; Virus Diseases; Chikungunya Fever
• Other Study ID Numbers: 2018/CHU/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No