Immune Dysfunction in Newborn Sepsis (RECIPAL)

bioMérieux

Status: Completed

Conditions: Malaria; Immune Responses; Sepsis Newborn

Treatments: Other: Non applicable

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03780712

RECIPAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 585 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

585 participants in 1 patient group

Sepsis Risk Group

Description:

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

Treatment:

Other: Non applicable