Against Chikungunya Virus and Neonatal Infection

NCT ID: NCT07190560

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-04-01

Brief Summary

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

Conditions

Chikungunya Virus Infection; Neonatal; Transfusion; Encephalopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plasma transfusion in newborns whose mothers are infected with chikungunya around the time of birth.

Biological and medical examination from Day 1 to Day 7 and at a visit between 1 and 3 months

Group Type: EXPERIMENTAL

plasma transfusion : PC-CHIK-V

Intervention Type: 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

Parallel observational cohort

No intervention, secondary using of care data collected, during standard cares, for the research

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

plasma transfusion : PC-CHIK-V

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU La Réunion

Saint-Pierre, , France

Countries

France

Facility Contacts

IACOBELLI

Role: primary

promotion.drci@chu-reunion.fr

+262262359000

Other Identifiers

2025/RUN/0036

Identifier Type: -

Identifier Source: org_study_id