NCT03780712

Immune Dysfunction in Newborn Sepsis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: BioMérieux · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis Newborn
• Malaria
• Immune Responses

Interventions

Type	Name	Description
OTHER	Non applicable	No intervention as it is an observational study

Timeline

• Start date: 2016-04-17
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2018-12-19
• Last updated: 2018-12-19