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NCT Number: NCT04909411

Consequences of a Maternal-fetal Chikungunya Virus Infection

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.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de La Réunion

Saint-Pierre, 97410, Reunion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OPHTHALMOLOGICAL ASSESSMENT

Other

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

Neuropsychological assessment

Other

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

Primary outcomes

  1. Total intelligence quotient

    Time frame: Month 3 (+/- 1 month)

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: CHIK13+

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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