Plasma transfusion to protect newborns exposed to chikungunya from brain inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Newborns whose mothers have a clinical or laboratory diagnosis of chikungunya within two days before to two days after delivery may receive a transfusion of plasma collected from donors who reported chikungunya infection within the past six months. Treated infants are monitored with daily clinical visits and biological tests through day 7 and have one follow-up visit between one and three months. Outcomes are compared to an observational cohort of newborns who did not receive transfusion because of diagnostic or transfer delays or parental refusal. The primary outcome is the proportion of newborns surviving without encephalitis/encephalopathy within the first five days of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Guyane , site de Cayenne
  Cayenne, French Guiana Recruiting
• Centre hospitalier de Mayotte
  Mamoudzou, Mayotte Recruiting
• CHU La Réunion
  Saint-Pierre, France Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.