Can donated plasma shield newborns from chikungunya brain damage?
NCT ID NCT07190560
First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This study tests whether giving newborns plasma from people who recently recovered from chikungunya can prevent brain swelling or damage. The trial will include 60 newborns whose mothers were infected around the time of birth. Half will receive the plasma transfusion, and their outcomes will be compared to a group of 30 similar newborns who did not receive the treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- plasma from recovered chikungunya patients
- What this could lead to
- If it works, this could provide a way to protect newborns from severe brain complications after chikungunya infection.
- What could go wrong
- This is a small, early-stage trial with only 60 participants, so results may not be conclusive. The treatment involves a plasma transfusion, which carries risks like allergic reactions or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 2 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Treatment group 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): * 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. * If the maternal infection was diagnosed between 1 day and 2 days after birth, treatment can be administered within 12 hours of diagnosis. * 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: * Whose mother has a clinical and/or laboratory diagnosis of CHIK-V 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. * Not treated with PC-CHIK-V: * Monitored in one of the units of the Neonatology Department for at least 5 days from the day of birth. * Whose holders of parental authority (or the holder if the mother is the sole holder of parental authority) have been informed of the research and have not objected to the use of data collected during hospitalization for research purposes. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU La Réunion
NOT_YET_RECRUITINGSaint-Pierre, 97410, France
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CHU de Guyane , site de Cayenne
RECRUITINGCayenne, French Guiana
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Centre hospitalier de Mayotte
RECRUITINGMamoudzou, Mayotte
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Other studies related to the condition(s) this trial covers.
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- How much lidocaine reaches a newborn during an urgent C-Section?
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- Can a gentle touch soothe preterm babies on breathing machines?
- Can less be more? testing transfusion limits in ECMO
- Can a single shot shield children from chikungunya?