Actively Recruiting
Against Chikungunya Virus and Neonatal Infection
Led by Centre Hospitalier Universitaire de la Réunion · Updated on 2026-05-08
60
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, whose mother has a peripartum chikungunya infection, will have an impact on the proportion of newborns surviving without encephalitis/encephalopathy (EE) within the first 5 days of life. Researchers will compare results to an observational study of 30 newborns who couldn't have been proposed to participate at the clinical trial, because of delay of diagnosis or delay of transfer to hospital which doesn't allow transfusion or parents not accepting plasma transfusion to the newborn. Participants of the clinical trial will: * receive a transfusion, * visit the clinic and undergo biological tests every day until day 7 and once between 1 and 3 months. Participant of observational study as part of their regular medical care, and biological data will be reused for the research from the mother's diagnosis until the newborn reaches 3 months of age
CONDITIONS
Official Title
Against Chikungunya Virus and Neonatal Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn whose mother has clinical and/or laboratory diagnosis of Chikungunya infection within 2 days before to 2 days after birth
- Hospitalized in a Level III neonatology unit in Mayotte or at the University Hospital of La Réunion
- Eligible for PC-CHIK-V treatment: if maternal infection diagnosed between 2 days before and the day of delivery, treatment given within 12 hours of birth
- If maternal infection diagnosed between 1 and 2 days after birth, treatment given within 12 hours of diagnosis
- Parental authority holders have given free, informed, written consent prior to any research examination
- For observational cohort: newborns with maternal Chikungunya diagnosis in same time frame and hospitalization, not treated with PC-CHIK-V
- Observational cohort newborns monitored at least 5 days from birth and parental authority holders informed and do not object to data use
You will not qualify if you...
- Newborns with clinical signs of hypoxic-ischemic encephalopathy requiring therapeutic hypothermia at birth
- Newborns requiring phototherapy at enrollment using devices with maximum energy wavelength less than 425 nm or emission bandwidth lower limit below 375 nm
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU La Réunion
Saint-Pierre, France, 97410
Not Yet Recruiting
2
Centre hospitalier de Mayotte
Mamoudzou, Mayotte
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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