@article{fdi:010082214, title = {{SEPSIS} project : a protocol for studying biomarkers of neonatal sepsis and immune responses of infants in a malaria-endemic region}, author = {{F}ievet, {N}adine and {E}zinmegnon, {S}. and {A}gbota, {G}ino and {S}ossou, {D}. and {L}adekpo, {R}. and {G}bedande, {K}. and {B}riand, {V}al{\'e}rie and {C}ottrell, {G}illes and {V}achot, {L}. and {M}arcos, {J}. {Y}. and {P}achot, {A}. and {T}extoris, {J}. and {B}lein, {S}. and {L}austen-{T}homsen, {U}. and {M}assougbodji, {A}. and {B}agnan, {L}. and {T}chiakpe, {N}. and {D}'{A}lmeida, {M}. and {A}lao, {J}. and {D}ossou-{D}agba, {I}. and {T}issieres, {P}. and {S}epsis {S}tudy {G}roup {C}ollaborators and {S}epsis {S}tudy {G}roup}, editor = {}, language = {{ENG}}, abstract = {{I}ntroduction {N}eonatal sepsis outreaches all causes of neonatal mortality worldwide and remains a major societal burden in low and middle income countries. {I}n 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. {N}evertheless, thoughtful epidemiological, diagnostic and immunological evaluation of neonatal sepsis and the impact of gestational malaria have never been performed. {M}ethods and analysis {A} prospective longitudinal multicentre follow-up of 580 infants from birth to 3months of age in urban and suburban {B}enin will be performed. {A}t delivery, and every other week, all children will be examined and clinically evaluated for occurrence of sepsis. {A}t delivery, cord blood systematic analysis of selected plasma and transcriptomic biomarkers (procalcitonin, interleukin ({IL})-6, {IL}-10, {IP}10, {CD}74 and {CX}3{CR}1) associated with sepsis pathophysiology will be evaluated in all live births as well as during the follow-up, and when sepsis will be suspected. {I}n addition, whole blood response to selected innate stimuli and extensive peripheral blood mononuclear cells phenotypic characterisation will be performed. {R}eference intervals specific to sub-{S}aharan neonates will be determined from this cohort and biomarkers performances for neonatal sepsis diagnosis and prognosis tested. {E}thics and dissemination {E}thical approval has been obtained from the {C}omite d'{E}thique de la {R}echerche - {I}nstitut des {S}ciences {B}iomedicales {A}ppliquees ({CER}-{ISBA} 85 - 5 {A}pril 2016, extended on 3 {F}ebruary 2017). {R}esults will be disseminated through international presentations at scientific meetings and publications in peer-reviewed journals. {T}rial registration number {C}linical{T}rials.gov registration number: {NCT}03780712.}, keywords = {neonatal intensive & critical care ; neonatology ; paediatric infectious ; disease and immunisation ; immunology ; {BENIN} ; {AFRIQUE} {SUBSAHARIENNE}}, booktitle = {}, journal = {{BMJ} {O}pen}, volume = {10}, numero = {7}, pages = {e036905 [9 ]}, ISSN = {2044-6055}, year = {2020}, DOI = {10.1136/bmjopen-2020-036905}, URL = {https://www.documentation.ird.fr/hor/fdi:010082214}, }