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Completed

NCT Number: NCT03780712

Immune Dysfunction in Newborn Sepsis

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non applicable

Other

No intervention as it is an observational study

Primary outcomes

  1. Evaluate Procalcitonin (PCT) for early onset neonatal sepsis diagnostic

    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

Secondary outcomes

  1. Evaluate Procalcitonin (PCT) for late onset neonatal sepsis diagnostic

    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

  2. To draw Procalcitonin (PCT) expression profile during 12 weeks after birth

    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

  3. Evaluate 2 host biomarkers mRNA expression (CD74 and CX3CR1) to prognostic neonatal sepsis

    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)

  4. FilmArray panels for early diagnosis of neonatal sepsis

    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

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Institut de Recherche Clinique du Benin
  • Institut de Recherche pour le Developpement

Registry information

Official study title

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

Acronym: RECIPAL

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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