Consequences of a Maternal-fetal Chikungunya Virus Infection

Chikungunya Virus Infection Clinical Trial

— CHIK13+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04909411
• Other study ID #: 2018/CHU/07
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus Infection
• Communicable Diseases
• Infections
• Virus Diseases

Intervention

Other:
• OPHTHALMOLOGICAL ASSESSMENT
assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination
• NEUROPSYCHOLOGICAL ASSESSMENT
completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire

Locations

Country	Name	City	State
Réunion	CHU de La Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intelligence quotient	Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5	Month 3 (+/- 1 month)