Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis Newborn
- Sponsor
- BioMérieux
- Enrollment
- 585
- Primary Endpoint
- Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic
Time Frame: 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
Secondary Outcomes
- 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)