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NCT Number: NCT07190560

Against Chikungunya Virus and Neonatal Infection

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

Recruiting

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Key information

Age range

0 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU La Réunion, Saint-Pierre, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

    Time frame: Five days after inclusion

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: ConvictionCHIK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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