Plasma transfusion to protect newborns exposed to chikungunya from brain inflammation

Against Chikungunya Virus and Neonatal Infection

This trial will test whether giving plasma from a recent chikungunya-infected donor to newborns whose mothers had chikungunya around delivery helps prevent encephalitis or encephalopathy in the first five days of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 0 Days to 2 Days
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de la Réunion (Academic / other)
• Locations: 2 sites (Saint-Pierre and 1 other locations)
• Trial ID: NCT07190560 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are newborns hospitalized in a Level III neonatology unit in La Réunion or Mayotte whose mothers had chikungunya diagnosed between two days before and two days after delivery and whose parents give informed consent within the treatment time windows.

Not a fit: Newborns diagnosed or transferred too late for timely transfusion, or whose parents decline plasma transfusion, are not eligible for the intervention and therefore may not receive any direct benefit from this treatment approach.

Why it matters

Potential benefit: If successful, this approach could reduce early neonatal encephalitis/encephalopathy and improve short-term survival and neurological outcomes for infants exposed to peripartum chikungunya.

How similar studies have performed: Use of convalescent or donor plasma for neonatal chikungunya is largely novel with limited direct evidence, though convalescent plasma has shown mixed and context-dependent results in other viral infections.

Eligibility criteria

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 this trial is running

Saint-Pierre and 1 other locations

• CHU La Réunion — Saint-Pierre, France (Not_yet_recruiting)
• Centre hospitalier de Mayotte — Mamoudzou, Mayotte (Recruiting)

Conditions Chikungunya Virus Infection; Neonatal; Transfusion; Encephalopathy