BMJ Open (Jul 2020)
SEPSIS project: a protocol for studying biomarkers of neonatal sepsis and immune responses of infants in a malaria-endemic region
- Karen Brengel-Pesce,
- Achille Massougbodji,
- Ida Dossou-Dagba,
- Dissou Affolabi,
- Darius Sossou,
- Benjamin Hounkpatin,
- Ulrik Lausten-Thomsen,
- Jules Alao,
- Nadine Fievet,
- Alexandre Pachot,
- Valerie Briand,
- Sem Ezinmegnon,
- Gino Agbota,
- Rodolphe Ladekpo,
- Komi Gbedande,
- Gilles Cottrell,
- Laurence Vachot,
- Javier Yugueros Marcos,
- Julien Textoris,
- Sophie Blein,
- Lehila Bagnan,
- Nicole Tchiakpe,
- Marceline d'Almeida,
- Pierre Tissieres,
- Aurax Fernando,
- Urbain Ahouayito,
- Basile Agossou,
- Caleb Ezinmegnon,
- Anauel Fortunato,
- Josué Fiagbenou,
- Djamirou Dossa,
- Dramane Abdou,
- Canisius Fantodji,
- Nawal Sare,
- Wilisto Bara,
- Razack Monde,
- Erasme Gbagidi,
- Larissa Allokpe,
- Armand Housemenou,
- Landry Assongba,
- Manfred Accrombessi,
- Florent Kouhouenou,
- Armand Hounsemenou,
- Amour Ridagba,
- Christiane Aguemon,
- Réné Perrin,
- Dossou Dagba,
- Luis Augusto,
- Sophie Thibault,
- François Bartolo,
- Marine Mommert
Affiliations
- Karen Brengel-Pesce
- Achille Massougbodji
- Faculté des Sciences de la Santé, Université d`Abomey-Calavi, Cotonou, Littoral, Benin
- Ida Dossou-Dagba
- 6 Paediatric Department, Calavi Hospital, Calavi, Benin
- Dissou Affolabi
- 5 Centre National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin
- Darius Sossou
- Institut de Recherche Clinique du Bénin, Calavi, Benin
- Benjamin Hounkpatin
- 5University of Abomey Calavi, BP, Benin
- Ulrik Lausten-Thomsen
- Pediatric Intensive Care, Hopitaux Universitaires Paris-Sud, Le Kremlin-Bicetre, France
- Jules Alao
- Paediatric Department, Mother and Child University and Hospital Center (CHU-MEL), Cotonou, Benin
- Nadine Fievet
- MERIT (Mère et Enfant Face aux Infections Tropicales)-UMR 216, Institut de Recherche pour le Développement (IRD), Université Paris Descartes, Paris, France
- Alexandre Pachot
- EA 7426 Pathophysiology of Injury-Induced Immunosuppression, bioMerieux, LYON cedex 03, France
- Valerie Briand
- Institut de Recherche pour le Développement (IRD), Mère et enfant face aux infections tropicales (UMR216), Paris, France
- Sem Ezinmegnon
- Department of Microbiology, Institut de Biologie Integrative de la Cellule, Gif-sur-Yvette, France
- Gino Agbota
- UMR216-MERIT, French National Research Institute for Sustainable Development (IRD), Université Paris Descartes, Paris, France
- Rodolphe Ladekpo
- Institut de Recherche Clinique du Bénin, Calavi, Benin
- Komi Gbedande
- Institut de Recherche Clinique du Benin, Cotonou, Benin
- Gilles Cottrell
- UMR216, Institut de Recherche pour le Développement, Cotonou, Benin
- Laurence Vachot
- Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l`Etoile, Rhône-Alpes, France
- Javier Yugueros Marcos
- Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l`Etoile, Rhône-Alpes, France
- Julien Textoris
- EA 7426 Pathophysiology of Injury-Induced Immunosuppression, bioMerieux, LYON cedex 03, France
- Sophie Blein
- Medical Diagnostic Discovery Department (MD3), bioMerieux SA, Marcy l`Etoile, Rhône-Alpes, France
- Lehila Bagnan
- Institut de Recherche Clinique du Bénin, Calavi, Benin
- Nicole Tchiakpe
- Institut de Recherche Clinique du Bénin, Calavi, Benin
- Marceline d'Almeida
- Department of Paediatric, National University Hospital Center (CNHU), Cotonou, Benin
- Pierre Tissieres
- Paediatric Intensive Care Unit, Hospital Bicetre, Le Kremlin-Bicetre, Île-de-France, France
- Aurax Fernando
- Urbain Ahouayito
- Basile Agossou
- Caleb Ezinmegnon
- Anauel Fortunato
- Josué Fiagbenou
- Djamirou Dossa
- Dramane Abdou
- Canisius Fantodji
- 1Centre Armand-Frappier Santé Biotechnologie, Institut national de la recherche scientifique, Laval, QC, Canada
- Nawal Sare
- Wilisto Bara
- Razack Monde
- Erasme Gbagidi
- Larissa Allokpe
- Armand Housemenou
- Landry Assongba
- Manfred Accrombessi
- Florent Kouhouenou
- Armand Hounsemenou
- Amour Ridagba
- Christiane Aguemon
- Réné Perrin
- Dossou Dagba
- Luis Augusto
- Sophie Thibault
- François Bartolo
- Marine Mommert
- DOI
- https://doi.org/10.1136/bmjopen-2020-036905
- Journal volume & issue
-
Vol. 10,
no. 7
Abstract
Introduction Neonatal sepsis outreaches all causes of neonatal mortality worldwide and remains a major societal burden in low and middle income countries. In addition to limited resources, endemic morbidities, such as malaria and prematurity, predispose neonates and infants to invasive infection by altering neonatal immune response to pathogens. Nevertheless, thoughtful epidemiological, diagnostic and immunological evaluation of neonatal sepsis and the impact of gestational malaria have never been performed.Methods and analysis A prospective longitudinal multicentre follow-up of 580 infants from birth to 3 months of age in urban and suburban Benin will be performed. At delivery, and every other week, all children will be examined and clinically evaluated for occurrence of sepsis. At delivery, cord blood systematic analysis of selected plasma and transcriptomic biomarkers (procalcitonin, interleukin (IL)-6, IL-10, IP10, CD74 and CX3CR1) associated with sepsis pathophysiology will be evaluated in all live births as well as during the follow-up, and when sepsis will be suspected. In addition, whole blood response to selected innate stimuli and extensive peripheral blood mononuclear cells phenotypic characterisation will be performed. Reference intervals specific to sub-Saharan neonates will be determined from this cohort and biomarkers performances for neonatal sepsis diagnosis and prognosis tested.Ethics and dissemination Ethical approval has been obtained from the Comité d’Ethique de la Recherche – Institut des Sciences Biomédicales Appliquées (CER-ISBA 85 - 5 April 2016, extended on 3 February 2017). Results will be disseminated through international presentations at scientific meetings and publications in peer-reviewed journals.Trial registration number ClinicalTrials.gov registration number: NCT03780712.
