At a glance
ClinicalIndex Comparison Record- ✓Newborn whose mother has clinical and/or laboratory diagnosis of Chikungunya infection occurring between 2 days before and 2 days after birth
- ✓Hospitalized in a Level III neonatology unit in Mayotte or University Hospital of La Réunion
- ✓Eligible for experimental treatment PC-CHIK-V with treatment administration within 12 hours of life or diagnosis depending on timing of maternal infection diagnosis
- ✓Parental authority holders have given free, informed, and written consent prior to any examination required for research
- ✕Newborns presenting at birth with hypoxic-ischemic encephalopathy requiring therapeutic hypothermia per national protocol
- ✕Newborns requiring phototherapy with devices having maximum energy wavelength less than 425 nm and/or emission bandwidth lower limit less than 375 nm
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Against Chikungunya Virus and Neonatal Infection
In Brief
A clinical study evaluating plasma transfusion : PC-CHIK-V for Chikungunya Virus Infection and 3 related conditions. Currently recruiting, targeting 60 participants across 2 sites in 2 countries.
Detailed 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, 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
Study Details
Timeline
Interventions
plasma 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