Viewing Study NCT04909411



Ignite Creation Date: 2024-05-06 @ 4:11 PM
Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04909411
Status: COMPLETED
Last Update Posted: 2024-01-05
First Post: 2021-05-28

Brief Title: Consequences of a Maternal-fetal Chikungunya Virus Infection
Sponsor: Centre Hospitalier Universitaire de la Réunion
Organization: Centre Hospitalier Universitaire de la Réunion

Study Overview

Official Title: Consequences of a Maternal-fetal Chikungunya Virus Infection Neurocognitive and Sensory Assessment Around the Age of 13
Status: COMPLETED
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CHIK13
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 155 and 483 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 CAMSP 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None