Against Chikungunya Virus and Neonatal Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorCentre Hospitalier Universitaire de la Réunion
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treatment group
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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
plasma transfusion : PC-CHIK-V
Biological/Vaccineplasma transfusion , from 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth.Experimental treatment 1 intervention
Group B: Parallel observational cohortNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Evaluate the efficacy of early administration of PC-CHIK-V in preventing the occurrence of neonatal CHIK-V encephalitis/encephalopathy (EE) in newborns whose mothers have peripartum CHIK-V infection.
The primary outcome measure is the proportion of newborns treated with PC-CHIK-V surviving without encephalitis/encephalopathy (EE) within the first 5 days of life.
Time frame
Five days after inclusionSponsors and contacts
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Source ClinicalTrials.gov