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Immune Dysfunction in Newborn Sepsis (RECIPAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780712
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Institut de Recherche pour le Developpement
Centre National de la Recherche Scientifique, France
IRCB (Institut de la Recherche Clinique du Bénin)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sepsis Newborn Malaria Immune Responses Other: Non applicable

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.

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Study Type : Observational
Actual Enrollment : 585 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neonatal Immune Dysfunction Associated to the Risk of Newborn Sepsis in Benin
Actual Study Start Date : April 17, 2016
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sepsis Risk Group
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
Other: Non applicable
No intervention as it is an observational study




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood heparin tube Whole blood PAXgene Whole blood EDTA Dry Blood Spot Faeces Ficoll processed mononuclear cells Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BioMérieux
ClinicalTrials.gov Identifier: NCT03780712    
Other Study ID Numbers: RECIPAL
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Immune System Diseases
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases