Immune Dysfunction in Newborn Sepsis

Completed

• Conditions: Malaria; Sepsis Newborn; Immune Responses
• Interventions: Other: Non applicable

• Registration Number: NCT03780712
• Lead Sponsor: BioMérieux

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.

Study Timeline

• Study Start: 2016-04-17
• Primary Completion: 2018-03-12
• Study Completion: 2018-03-12
• Study First Submitted: 2018-03-13
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 585

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis Risk Group	Non applicable	419 infants born from mothers at risk to deliver babies with neonatal infections in Cotonou hospitals (Benin) 166 infants without sepsis born from mothers enrolled in a study to monitor pregnancy-associated malaria and Intrauterine growth restriction in Benin

Primary Outcome Measures

Name	Time	Method
Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic	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 Outcome Measures

Name	Time	Method
Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis	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)
FilmArray panels for early diagnosis of neonatal sepsis	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
To draw Procalcitonin (PCT) expression profile during 12 weeks after birth	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
Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic	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