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

Primary Purpose

Chikungunya Virus Infection

Status
Unknown status
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
OPHTHALMOLOGICAL ASSESSMENT
NEUROPSYCHOLOGICAL ASSESSMENT
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chikungunya Virus Infection

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • CHU de La RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Exposed arm

Non-exposed arm

Arm Description

child infected with chikungunya virus during childbirth

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 28, 2021
Last Updated
June 2, 2021
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT04909411
Brief Title
Consequences of a Maternal-fetal Chikungunya Virus Infection
Acronym
CHIK13+
Official Title
Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
June 12, 2021 (Anticipated)
Study Completion Date
January 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposed arm
Arm Type
Other
Arm Description
child infected with chikungunya virus during childbirth
Arm Title
Non-exposed arm
Arm Type
Other
Arm Description
child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified
Intervention Type
Other
Intervention Name(s)
OPHTHALMOLOGICAL ASSESSMENT
Intervention Description
assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination
Intervention Type
Other
Intervention Name(s)
NEUROPSYCHOLOGICAL ASSESSMENT
Intervention Description
completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire
Primary Outcome Measure Information:
Title
Total intelligence quotient
Description
Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5
Time Frame
Month 3 (+/- 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir MEDJANE, PhD
Phone
+262(0)267359750
Email
samir.medjane@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaelle SARTON, MD
Organizational Affiliation
CHU de La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de La Réunion
City
Saint-Pierre
ZIP/Postal Code
97410
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaelle SARTON, MD

12. IPD Sharing Statement

Learn more about this trial

Consequences of a Maternal-fetal Chikungunya Virus Infection

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