Consequences of a Maternal-fetal Chikungunya Virus Infection

NCT04909411 | Completed

• 1 other identifier: 2018/CHU/07
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total intelligence quotient

  Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5

  Month 3 (+/- 1 month)

Study Arms (2)

Exposed arm

OTHER

child infected with chikungunya virus during childbirth

Other: OPHTHALMOLOGICAL ASSESSMENT; Other: NEUROPSYCHOLOGICAL ASSESSMENT

Non-exposed arm

OTHER

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

Other: OPHTHALMOLOGICAL ASSESSMENT; Other: NEUROPSYCHOLOGICAL ASSESSMENT

Interventions

OPHTHALMOLOGICAL ASSESSMENT OTHER

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

Exposed arm; Non-exposed arm

NEUROPSYCHOLOGICAL ASSESSMENT OTHER

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

Exposed arm; Non-exposed arm

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de La Réunion

Saint-Pierre, 97410, Reunion

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Raphaelle SARTON, MD

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: January 13, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

RE (1)