Consequences of a Maternal-fetal Chikungunya Virus Infection

NCT ID: NCT04909411

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2021-10-12

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Exposed arm

child infected with chikungunya virus during childbirth

Group Type: OTHER

OPHTHALMOLOGICAL ASSESSMENT

Intervention Type: OTHER

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

NEUROPSYCHOLOGICAL ASSESSMENT

Intervention Type: OTHER

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

Non-exposed arm

child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified

Group Type: OTHER

OPHTHALMOLOGICAL ASSESSMENT

Intervention Type: OTHER

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

NEUROPSYCHOLOGICAL ASSESSMENT

Intervention Type: OTHER

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

Interventions

OPHTHALMOLOGICAL ASSESSMENT

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

Intervention Type: OTHER

NEUROPSYCHOLOGICAL ASSESSMENT

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaelle SARTON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Locations

CHU de La Réunion

Saint-Pierre, , Reunion

Countries

Reunion

Other Identifiers

2018/CHU/07

Identifier Type: -

Identifier Source: org_study_id