Non applicable
OtherNo intervention as it is an observational study
NCT Number: NCT03780712
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.
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Observational
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 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the sepsis risk group (400 infants):
Inclusion criteria
for the control group (170 infants):
Exclusion criteria
for both groups:
No intervention as it is an observational study
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
Time frame: At one week after birth
To measure in peripheral blood the association and performance of PCT and the diagnosis of late onset neonatal sepsis for infants at risk to develop infection
Time frame: Twelve weeks follow-up after birth
To measure PCT concentration during 12 weeks (sampling at birth, week 1, week 4, week 8 and week 12) and explore the relevance of host biomarker-driven antibiotherapy in a low-income country
Time frame: Twelve weeks follow-up after birth
To measure CD74 and CX3CR1 mRNA expression in order to evaluate their performance on the early prognostic of neonatal sepsis for infants at risk to develop infections (occurrence of secondary infections and mortality rate)
Time frame: Twelve weeks follow-up after birth
To test commercial FilmArray panels in order to evaluate the role of novel diagnostic techniques as part of the diagnostic algorithm on the early diagnosis of neonatal sepsis over a period of 12 weeks for infants at risk to develop infection
BioMérieux
Industry
Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
Acronym: RECIPAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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