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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909411
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Other: OPHTHALMOLOGICAL ASSESSMENT Other: NEUROPSYCHOLOGICAL ASSESSMENT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : June 12, 2021
Estimated Study Completion Date : January 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Total intelligence quotient [ Time Frame: Month 3 (+/- 1 month) ]
    Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909411


Contacts
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Contact: Samir MEDJANE, PhD +262(0)267359750 samir.medjane@chu-reunion.fr

Locations
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Réunion
CHU de La Réunion Recruiting
Saint-Pierre, Réunion, 97410
Contact: Raphaelle SARTON, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Principal Investigator: Raphaelle SARTON, MD CHU de La Réunion
More Information
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04909411    
Other Study ID Numbers: 2018/CHU/07
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Infections
Communicable Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
 Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Togaviridae Infections
RNA Virus Infections