Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT07190560
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
2 Days
Study:
NCT07190560
Study Brief:
Protocol Section:
NCT07190560