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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if giving plasma from a donor who recently had Chikungunya infection to newborns whose mothers have peripartum Chikungunya infection can improve the chances of newborns surviving without brain inflammation or damage within the first five days of life. The study will compare these results with a group of newborns who did not receive plasma transfusion due to delays in diagnosis or transfer, or parental refusal. The trial is led by the Centre Hospitalier Universitaire de la Réunion and includes newborns up to 2 days old. Participants in the treatment group will receive a plasma transfusion from donors who declared Chikungunya infection less than six months ago. This treatment is given to newborns whose mothers were diagnosed with Chikungunya infection around the time of birth. Newborns will be treated within 12 hours of birth or diagnosis depending on timing. There is also a parallel observational group of newborns who will not receive plasma but will be monitored as part of standard care. During the study, newborns will have daily medical and biological tests from day 1 to day 7, and a follow-up visit between 1 and 3 months of age. For the observational group, data collected during routine care up to 3 months will be used for research. Researchers will measure the effectiveness of early plasma administration in preventing neonatal brain inflammation or damage within five days after treatment. Safety and health will be monitored throughout the trial period, which is planned to end in late 2027.
CONDITIONS
Brief Title
Against Chikungunya Virus and Neonatal Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn whose mother has a clinical or laboratory diagnosis of Chikungunya infection 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 plasma transfusion treatment (PC-CHIK-V) with treatment timing depending on maternal infection diagnosis
- Parental authority holders have given free, informed, and written consent prior to research examinations
- For observational cohort: newborns not treated with plasma but monitored for at least 5 days and whose parents have not objected to data use
You will not qualify if you...
- Newborns with clinical criteria for hypoxic-ischemic encephalopathy requiring therapeutic hypothermia
- Newborns requiring phototherapy treatment using devices with maximum energy wavelength less than 425 nm or emission bandwidth lower limit below 375 nm at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day 1 to Day 7 after birth
Participants receive plasma transfusion from donors who had a recent chikungunya infection to prevent neonatal chikungunya encephalitis.
Daily visits for up to 7 days
Duration - Between 1 and 3 months after treatment
Participants have a follow-up visit to assess health status between 1 and 3 months after birth.
1 visit (in-person)
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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