Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03780712
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2018-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Dysfunction in Newborn Sepsis
Sponsor:
BioMérieux
Organization:
Study Overview
Official Title:
Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECIPAL
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: