Against Chikungunya Virus and Neonatal Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment group
- •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)
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: plasma transfusion : PC-CHIK-V (Biological)
Parallel observational cohort
No intervention, secondary using of care data collected, during standard cares, for the research
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点