{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T22:11:10Z","timestamp":1785881470173,"version":"3.56.0"},"reference-count":21,"publisher":"Walter de Gruyter GmbH","issue":"9","funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["Current Research Funds"],"award-info":[{"award-number":["Current Research Funds"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Gepa S.r.l. Italy","award":["202103_GEPA_AURITI"],"award-info":[{"award-number":["202103_GEPA_AURITI"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-0128_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The diagnostic accuracy of presepsin (P-SEP) in the newborn is still under evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0128_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In a multicenter study, we studied the accuracy of P-SEP as a diagnostic marker of late-onset sepsis (LOS) in critical newborns with underlying disorders, to define the most accurate cut-off to distinguish infected from uninfected patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0128_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty-nine\/351 newborns without infections at admission developed LOS. The median P-SEP value at T0 (admission) was 518.0\u202fng\/L (IQR 313.0\u2013789.0), without significant differences related to underlying diseases (p=0.52). In neonates who developed LOS, P-SEP increased at the onset of infection (T1) (median: 816.0 ng\/L) and after 24\u201348\u202fh (median: 901.0 ng\/L) compared with their value at admission (median: 560.0 ng\/L) (p&lt;0.01 and p=0.03, respectively). The area under the ROC curve at T1 was 0.71 (95\u202f% CI 0.65\u20130.78) when all cases of sepsis were included in the analysis and increased to 0.74 (95\u202f% CI 0.66\u20130.81) considering only confirmed sepsis. Approximately two-thirds of patients were correctly classified, setting the cut-off at 713\u202fng\/L, with a negative predictive value of 89.0\u00a0%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0128_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>At a cut-off of 713\u202fng\/L, P-SEP has good accuracy in diagnosing LOS in critically ill newborns. In uninfected newborns, the median value of P-SEP is not influenced by any underlying pathology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-0128","type":"journal-article","created":{"date-parts":[[2025,4,18]],"date-time":"2025-04-18T17:04:21Z","timestamp":1744995861000},"page":"1876-1887","source":"Crossref","is-referenced-by-count":4,"title":["The accuracy of presepsin in diagnosing neonatal late-onset sepsis in critically ill neonates: a prospective study"],"prefix":"10.1515","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9820-6557","authenticated-orcid":false,"given":"Cinzia","family":"Auriti","sequence":"first","affiliation":[{"name":"Saint Camillus International University of Health and Medical Sciences , Rome , Italy"},{"name":"Casa di Cura Villa Margherita , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico Umberto","family":"De Rose","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"},{"name":"Faculty of Medicine and Surgery , PhD Course in Microbiology, Immunology, Infectious Diseases, and Transplants (MIMIT), \u201cTor Vergata\u201d University of Rome , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Maddaloni","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucilla","family":"Rav\u00e0","sequence":"additional","affiliation":[{"name":"Epidemiology Unit \u2013\u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovica","family":"Martini","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Di Tommaso","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 Mediterranean Pediatric Cardiology Center , San Vincenzo Hospital , Taormina , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Bernaschi","sequence":"additional","affiliation":[{"name":"Microbiology Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuel","family":"Paionni","sequence":"additional","affiliation":[{"name":"Clinical Chemistry Laboratory Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ottavia","family":"Porzio","sequence":"additional","affiliation":[{"name":"Clinical Chemistry Laboratory Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"},{"name":"Department of Experimental Medicine , University of Rome \u201cTor Vergata\u201d , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiammetta","family":"Piersigilli","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit , Cliniques Universitaires Saint Luc, Universit\u00e9 Catholique de Louvain , Bruxelles , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Iannetta","sequence":"additional","affiliation":[{"name":"Tor Vergata University Hospital , Infectious Disease Clinic , Department of Systems Medicine , Tor Vergata University , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Dotta","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Paola","family":"Ronchetti","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit \u2013 \u201cBambino Ges\u00f9\u201d Children\u2019s Hospital IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2025,4,21]]},"reference":[{"key":"2026051215061116613_j_cclm-2025-0128_ref_001","doi-asserted-by":"crossref","unstructured":"Zea-Vera, A, Ochoa, TJ. 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CDC\/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 2008;36:309\u201332. https:\/\/doi.org\/10.1016\/j.ajic.2008.03.002.","DOI":"10.1016\/j.ajic.2008.03.002"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_011","doi-asserted-by":"crossref","unstructured":"Auriti, C, Ronchetti, MP, Pezzotti, P, Marrocco, G, Quondamcarlo, A, Seganti, G, et al.. Determinants of nosocomial infection in 6 neonatal intensive care units: an Italian multicenter prospective cohort study. Infect Control Hosp Epidemiol 2010;31:926\u201333. https:\/\/doi.org\/10.1086\/655461.","DOI":"10.1086\/655461"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_012","doi-asserted-by":"crossref","unstructured":"Auriti, C, De Rose, DU, Santisi, A, Martini, L, Ronchetti, MP, Rav\u00e0, L, et al.. Incidence and risk factors of bacterial sepsis and invasive fungal infection in neonates and infants requiring major surgery: an Italian multicentre prospective study. J\u00a0Hosp Infect 2022;130:122\u201330. https:\/\/doi.org\/10.1016\/j.jhin.2022.09.018.","DOI":"10.1016\/j.jhin.2022.09.018"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_013","doi-asserted-by":"crossref","unstructured":"Kassis, C, Rangaraj, G, Jiang, Y, Hachem, RY, Raad, I. Differentiating culture samples representing coagulase-negative staphylococcal bacteremia from those representing contamination by use of time-to-positivity and quantitative blood culture methods. J\u00a0Clin Microbiol 2009;47:3255\u201360. https:\/\/doi.org\/10.1128\/jcm.01045-09.","DOI":"10.1128\/JCM.01045-09"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_014","doi-asserted-by":"crossref","unstructured":"Ruiz-Giard\u00edn, JM, Martin-D\u00edaz, RM, Jaqueti-Aroca, J, Garcia-Arata, I, San Mart\u00edn-L\u00f3pez, JV, S\u00e1iz-S\u00e1nchez Buitrago, M. Diagnosis of bacteraemia and growth times. Int J Infect Dis 2015;41:6\u201310. https:\/\/doi.org\/10.1016\/j.ijid.2015.10.008.","DOI":"10.1016\/j.ijid.2015.10.008"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_015","doi-asserted-by":"crossref","unstructured":"Mussap, M, Puxeddu, E, Burrai, P, Noto, A, Cibecchini, F, Testa, M, et al.. Soluble CD14 subtype (sCD14-ST) presepsin in critically ill preterm newborns: preliminary reference ranges. J\u00a0Matern Fetal Neonatal Med 2012;25:51\u20133. https:\/\/doi.org\/10.3109\/14767058.2012.717462.","DOI":"10.3109\/14767058.2012.717462"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_016","doi-asserted-by":"crossref","unstructured":"Poggi, C, Vasarri, MV, Boni, L, Pugni, L, Mosca, F, Dani, C. Reference ranges of Presepsin in preterm infants in the first 48\u00a0h of life: a multicenter observational study. Clin Chim Acta 2020;508:191\u20136. https:\/\/doi.org\/10.1016\/j.cca.2020.05.040.","DOI":"10.1016\/j.cca.2020.05.040"},{"key":"2026051215061116613_j_cclm-2025-0128_ref_017","doi-asserted-by":"crossref","unstructured":"Chiesa, C, Natale, F, Pascone, R, Osborn, JF, Pacifico, L, Bonci, E, et al.. C reactive protein and procalcitonin: reference intervals for preterm and term newborns during the early neonatal period. 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