ArticlePloS one2019
Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Vancomycin in neonatal patients: systematic review and call for standardized dosing and monitoring practices.European journal of clinical pharmacology · 2025Pooled it
- The Accuracy of 16S rRNA Polymerase Chain Reaction for the Diagnosis of Neonatal Sepsis: A Meta-Analysis.BioMed research international · 2021Pooled it
- Role of vitamin C infusion in postoperative mechanically ventilated neonates with sepsis: a randomized controlled trial.European journal of pediatrics · 2025Trial
- Neonatal sepsis definitions for randomised-controlled trials: challenges and approaches.International journal of epidemiology · 2026Article
- Epidemiology, microbiological profile, and antimicrobial resistance patterns of culture-proven neonatal sepsis in a tertiary NICU.BMC pediatrics · 2026Article
- Evaluation of the Course of Acute-Phase Reactants in the Postoperative Period of Newborns and Their Diagnostic Utility in Identifying Postoperative Sepsis.Diagnostics (Basel, Switzerland) · 2026Article
- Procalcitonin, Presepsin, Endocan, and Interleukin-6 in the Early Diagnosis of Neonatal Sepsis-A Prospective Study.Diagnostics (Basel, Switzerland) · 2025Article
- Assessment of Culture-Negative Neonatal Early-Onset Sepsis: Risk Factors and Utility of Currently Used Serum Biomarkers.Children (Basel, Switzerland) · 2025Article
- Multicentre external validation of the Neonatal Healthcare-associated infectiOn Prediction (NeoHoP) score: a retrospective case-control study.BMJ paediatrics open · 2024Observational
- Diagnostic and prognostic significance of apelin-13, APJ for sepsis in the emergency department: A prospective study.Heliyon · 2024Article
- Investigating the Association between Serum and Hematological Biomarkers and Neonatal Sepsis in Newborns with Premature Rupture of Membranes: A Retrospective Study.Children (Basel, Switzerland) · 2024Article
- Evaluating of neonatal early onset sepsis through lactate and base excess monitoring.Scientific reports · 2023Article
- Observational
- A Prospective, Case-Control Study of Serum Metabolomics in Neonates with Late-Onset Sepsis and Necrotizing Enterocolitis.Journal of clinical medicine · 2022Article
- Diagnostic Accuracy of Clinical Tool 'STOPS' and Serum Procalcitonin for Optimizing Antibiotic Therapy in Neonates Born at ≥ 28 Weeks of Gestation with Neonatal Sepsis.Mediterranean journal of hematology and infectious diseases · 2021Article
- miR-486-5p Serves as a Diagnostic Biomarker for Sepsis and Its Predictive Value for Clinical Outcomes.Journal of inflammation research · 2021Article
- Neonatal Sepsis Diagnosis Decision-Making Based on Artificial Neural Networks.Frontiers in pediatrics · 2020Article
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis.
methodsA multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.
resultsAmong the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.
conclusionsResults highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.
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