Status:
NOT_YET_RECRUITING
Against Chikungunya Virus and Neonatal Infection
Lead Sponsor:
Centre Hospitalier Universitaire de la Réunion
Conditions:
Chikungunya Virus Infection
Neonatal
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if administration of plasma, from a whole blood donation from an individual who has declared a Chikungunya infection for less than 6 months , to a newborn, ...
Eligibility Criteria
Inclusion
- Treatment group
- Newborn:
- whose mother has a clinical and/or laboratory diagnosis of Chikungunya (CHIK) infection occurring between 2 days before and 2 days after birth.
- Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.
- Eligible for experimental treatment (called PC-CHIK-V):
- If the maternal infection was diagnosed between2 days before and the day of delivery, treatment can be administered within the first 12 hours of the newborn's life.
- If the maternal infection was diagnosed between 1 day and 2 days after birth, treatment can be administered within 12 hours of diagnosis.
- Whose holders of parental authority have given free, informed, and written consent prior to any examination required for the research. Parallel Cohort of
- Untreated Newborns (parallel observational cohort)
- Newborns:
- Whose mother has a clinical and/or laboratory diagnosis of CHIK-V infection occurring between 2 days before and 2 days after birth.
- Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion.
- Not treated with PC-CHIK-V:
- Monitored in one of the units of the Neonatology Department for at least 5 days from the day of birth.
- Whose holders of parental authority (or the holder if the mother is the sole holder of parental authority) have been informed of the research and have not objected to the use of data collected during hospitalization for research purposes.
Exclusion
- Newborns who present at birth with clinical criteria for ahypoxic-ischemic encephalopathy (HIE) that require therapeutic hypothermia according to the national protocol for "neonatal therapeutic hypothermia"
- Newborns who require phototherapy treatment at the time of enrollment using devices with a maximum energy wavelength less than 425 nm and/or with an emission bandwidth with a lower limit of \<375 nm.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07190560
Start Date
November 1 2025
End Date
April 1 2027
Last Update
September 29 2025
Active Locations (1)
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1
CHU La Réunion
Saint-Pierre, France, 97410