跳至主要内容
临床试验/NCT03780712
NCT03780712已完成不适用

Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin

BioMérieux0 个研究点目标入组 585 人开始时间: 2016年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
BioMérieux
入组人数
585
主要终点
Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic

研究概览

简要总结

The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.

详细描述

The fetal immunological responses maturate gradually during the last 3 months of pregnancy. To respond to pathogens, newborns depend essentially on their innate immune system. Premature babies have a significant impairment of innate and immune regulatory functions, thus promoting neonatal sepsis. In addition, chronic infections during pregnancy, including those of parasitic origin, fetal immunity. In utero exposure to P. falciparum antigens impacts particularly the newborn immune development and is a risk factor predisposing to malaria and also to other infections during the first year of life.

The major objectives are to assess:

  • The relevance of a host biomarker driven diagnostic of sepsis in newborns,
  • The relevance of immune markers as indicators of sepsis incidence, secondary infections occurrence, and mortality
  • The role of novel diagnostic techniques (FilmArray panels) as part of the microbiological diagnostic,
  • The immunological profile of the infants in the 3 first months of life.

The targeted population is newborns with a high risk to develop sepsis recruited at delivery compared to a control infant population with a low infection risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic

时间窗: At birth

To measure in cord blood the association and performance of PCT and the early diagnosis of neonatal sepsis for infants at risk to develop infection

次要结局

  • Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis(Twelve weeks follow-up after birth)
  • FilmArray panels for early diagnosis of neonatal sepsis(Twelve weeks follow-up after birth)
  • To draw Procalcitonin (PCT) expression profile during 12 weeks after birth(Twelve weeks follow-up after birth)
  • Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic(At one week after birth)

研究者

发起方
BioMérieux
申办方类型
Industry
责任方
Sponsor

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