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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth. | Experimental | Biological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months |
|
| Parallel observational cohort | No Intervention | No intervention, secondary using of care data collected, during standard cares, for the research |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plasma transfusion : PC-CHIK-V | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Five days after inclusion |
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Inclusion Criteria:
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):
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU La Réunion | Not yet recruiting | Saint-Pierre | 97410 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42174470 | Derived | Iacobelli S, Laperche S, Pasquet A, Papa K, Maccio G, Guinaud J, Abasse S, Bardou M, Ferdynus C; CONVICTION-CHIK study group. CONVICTION-CHIK study on the effect of convalescent plasma for mother-to-child Chikungunya infection: protocol for a multicentre, open label, single-arm, phase II trial. BMC Pregnancy Childbirth. 2026 May 22. doi: 10.1186/s12884-026-09311-x. Online ahead of print. |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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| Centre hospitalier de Mayotte | Recruiting | Mamoudzou | Mayotte |
|
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |