biostudies-literatureHayes RMedical Research Council1141-1148https://www.ebi.ac.uk/biostudies/studies/S-EPMC10132965biostudies-literatureUnknown93(5)<h4>Introduction</h4>Neonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs).<h4>Method</h4>A systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis).<h4>Results</h4>Of 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by blooPediatric researchNeonatal sepsis definitions from randomised clinical trials.PMC10132965MR/N008405/1Kuster HRoche ECarroll LKoenig JMSemova GInfection, Inflammation, Immunology and Immunisation (I4) section of the European Society for Paediatric Research (ESPR)Murray CDegtyareva MHartnett JMurphy KWynn JLPlotz FBMeehan JMcGovern MPlapp HGiannoni EJenkins EGale CKeij FMMockler DHession Lde Boode WPBliss JMolloy EJO'Toole JReiss IKMStrunk TAllen JJanota JTurner MAHurley TSchlapbach LJMcCollum DPolin RHayes RfalseNeonatal sepsis definitions from randomised clinical trials.<h4>Introduction</h4>Neonatal sepsis is a leading cause of infant mortality worldwide with non-specific and varied presentation. We aimed to catalogue the current definitions of neonatal sepsis in published randomised controlled trials (RCTs).<h4>Method</h4>A systematic search of the Embase and Cochrane databases was performed for RCTs which explicitly stated a definition for neonatal sepsis. Definitions were sub-divided into five primary criteria for infection (culture, laboratory findings, clinical signs, radiological evidence and risk factors) and stratified by qualifiers (early/late-onset and likelihood of sepsis).<h4>Results</h4>Of 668 papers screened, 80 RCTs were included and 128 individual definitions identified. The single most common definition was neonatal sepsis defined by bloo2023-01-01T00:00:00Z2023 Apr2025-08-12T03:04:37.508Z2025-08-12T03:04:37.508ZS-EPMC101329653474318010.1038/s41390-021-01749-3