Immune Dysfunction in Newborn Sepsis

Malaria Clinical Trial

— RECIPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780712
• Other study ID #: RECIPAL
• Status: Completed
• Start date: April 17, 2016
• Est. completion date: March 12, 2018

Study information

• Verified date: December 2018
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria for the sepsis risk group (400 infants):

• Child born from mothers having one of the following criteria before delivery will be included in this study:

• Spontaneous preterm delivery (<37 weeks of gestation time)

• Foul smelling / with meconium / colored / bloody amniotic liquid

• Rupture of membranes > 18 hours

• Maternal fever at delivery

• Vaginal infection

• Child born at the maternity of CNHU (Centre National Hospitalier et Universitaire, Cotonou, Benin) or CHUMEL (Centre Hospitalier et Universitaire de la Mère et de l'Enfant Lagune, Cotonou, Benin) or HZAC (Hopital de zone d' Abomey-Calavi, Benin).

• Mother located near Abomey-Calavi. This criterion has been included to limit the follow-up expenses and spare the travel to the project staff in charge of the 3 month follow-up.

Inclusion Criteria for the control group (170 infants):

• Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and Intrauterine growth restriction in Benin)

Exclusion Criteria for both groups:

• HIV + status or unknown HIV status of the mother (as the mother and child will be part of the national program to take care of mother and child HIV+ at delivery)

• Parents do not consent to be included in the study.

Related Conditions & MeSH terms

• Immune Responses
• Immune System Diseases
• Malaria
• Neonatal Sepsis
• Sepsis
• Sepsis Newborn
• Toxemia

Intervention

Other:
• Non applicable
No intervention as it is an observational study

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
BioMérieux	Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, IRCB (Institut de la Recherche Clinique du Bénin)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic	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	At birth
Secondary	Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic	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	At one week after birth
Secondary	To draw Procalcitonin (PCT) expression profile during 12 weeks 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	Twelve weeks follow-up after birth
Secondary	Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis	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)	Twelve weeks follow-up after birth
Secondary	FilmArray panels for early diagnosis of neonatal sepsis	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	Twelve weeks follow-up after birth