SEPSIS project: a protocol for studying biomarkers of neonatal sepsis and immune responses of infants in a malaria-endemic region. Issue 7 (23rd July 2020)

• Record Type: Journal Article
• Authors: Fievet, Nadine; Ezinmegnon, Sem; Agbota, Gino; Sossou, Darius; Ladekpo, Rodolphe; Gbedande, Komi; Briand, Valerie; Cottrell, Gilles; Vachot, Laurence; Yugueros Marcos, Javier; Pachot, Alexandre; Textoris, Julien; Blein, Sophie; Lausten-Thomsen, Ulrik; Massougbodji, Achille; Bagnan, Lehila; Tchiakpe, Nicole; d'Almeida, Marceline; Alao, Jules; Dossou-Dagba, Ida; Tissieres, Pierre
• Other Names: author non-byline.; Fernando Aurax author non-byline.; Ahouayito Urbain author non-byline.; Agossou Basile author non-byline.; Ezinmegnon Caleb author non-byline.; Fortunato Anauel author non-byline.; Fiagbenou Josué author non-byline.; Dossa Djamirou author non-byline.; Abdou Dramane author non-byline.; Fantodji Canisius author non-byline.; Sare Nawal author non-byline.; Bara Wilisto author non-byline.; Monde Razack author non-byline.; Gbagidi Erasme author non-byline.; Allokpe Larissa author non-byline.; Housemenou Armand author non-byline.; Assongba Landry author non-byline.; Accrombessi Manfred author non-byline.; Kouhouenou Florent author non-byline.; Hounsemenou Armand author non-byline.; Ridagba Amour author non-byline.; Aguemon Christiane author non-byline.; Affolabi Dissou author non-byline.; Perrin Réné author non-byline.; Hounkpatin Benjamin author non-byline.; Dagba Dossou author non-byline.; Augusto Luis author non-byline.; Thibault Sophie author non-byline.; Bartolo François author non-byline.; Mommert Marine author non-byline.; Brengel-Pesce Karen author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 7(2020)
• Publication Date: 2020-07-23
• Subjects: neonatal intensive & critical care -- neonatology -- paediatric infectious disease & immunisation -- immunology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-036905
• Languages: English
• ISSNs: 2044-6055

Abstract

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 .