Chikungunya Virus InfectionCHIK13+NCT04909411
Consequences of a Maternal-fetal Chikungunya Virus Infection
A study testing OPHTHALMOLOGICAL ASSESSMENT and NEUROPSYCHOLOGICAL ASSESSMENT in people with Chikungunya Virus Infection, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- OPHTHALMOLOGICAL ASSESSMENT and NEUROPSYCHOLOGICAL ASSESSMENT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteReunion
- Study dates
- 13 Jan 2020to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.
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
- Being tested
- OPHTHALMOLOGICAL ASSESSMENT, NEUROPSYCHOLOGICAL ASSESSMENT
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPHTHALMOLOGICAL ASSESSMENTOther
assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination
NEUROPSYCHOLOGICAL ASSESSMENTOther
completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Exposed arm | Other | child infected with chikungunya virus during childbirth Receives: 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 Receives: Other: OPHTHALMOLOGICAL ASSESSMENT; Other: NEUROPSYCHOLOGICAL ASSESSMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intelligence quotient
Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5
Measured: Month 3 (+/- 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start13 Jan 2020
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaelle SARTON, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909411
- Sponsor's protocol ID
- 2018/CHU/07
- Acronym
- CHIK13+
- Status last verified
- Jan 2024
- First submitted
- 28 May 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarton R, Mery MO, Carbonnier M, Renouil M, Morice C, Medjane S, Bintner M, Boumahni B, Gerardin P. Long-term neurodevelopmental outcomes of children perinatally infected with chikungunya: the CHIK13+ matched cohort study on Reunion Island. EClinicalMedicine. 2026 May 18;95:103975. doi: 10.1016/j.eclinm.2026.103975. eCollection 2026 May.
PubMed 42205143
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.
- ClinicalTrials.gov ID
- NCT04909411
- Acronym / sponsor ID
- CHIK13+ / 2018/CHU/07
- Conditions
- Chikungunya Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed arm | Other | Other: OPHTHALMOLOGICAL ASSESSMENT, Other: NEUROPSYCHOLOGICAL ASSESSMENTchild infected with chikungunya virus during childbirth |
| Non-exposed arm | Other | Other: OPHTHALMOLOGICAL ASSESSMENT, Other: NEUROPSYCHOLOGICAL ASSESSMENTchild not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPHTHALMOLOGICAL ASSESSMENTassessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination | Other | Exposed arm, Non-exposed arm |
| NEUROPSYCHOLOGICAL ASSESSMENTcompletion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire | Other | Exposed arm, Non-exposed arm |
Primary outcome
Total intelligence quotient
Time frame: Month 3 (+/- 1 month)
Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 42205143Sarton R, Mery MO, Carbonnier M, Renouil M, Morice C, Medjane S, Bintner M, Boumahni B, Gerardin P. Long-term neurodevelopmental outcomes of children perinatally infected with chikungunya: the CHIK13+ matched cohort study on Reunion Island. EClinicalMedicine. 2026 May 18;95:103975. doi: 10.1016/j.eclinm.2026.103975. eCollection 2026 May.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaelle SARTON, MD principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPHTHALMOLOGICAL ASSESSMENT and NEUROPSYCHOLOGICAL ASSESSMENT in people with Chikungunya Virus Infection, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intelligence quotient (time frame: Month 3 (+/- 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.