Coagulation dysfunction in term neonatal sepsis: a prospective cohort study.

Objective: To characterize clinical features, conventional coagulation profiles, and rotational thromboelastometry (ROTEM) parameters in term neonates with sepsis, and to evaluate their associations with all-cause mortality within 28 days after sepsis diagnosis, with particular emphasis on whether a fibrin-based ROTEM parameter provides incremental prognostic information beyond organ dysfunction severity and conventional coagulation testing. Methods: This prospective hospital-based cohort study was conducted at the Neonatal Center of Vietnam National Children's Hospital between June 2024 and December 2025. Term neonates (gestational age 37-42 weeks) diagnosed with neonatal sepsis according to the European Medicines Agency 2010 criteria were enrolled. Clinical severity was assessed using the neonatal Sequential Organ Failure Assessment (nSOFA) score. Conventional coagulation tests included platelet count, prothrombin time/international normalized ratio (INR), aPTT ratio, fibrinogen, D-dimer, and selected natural anticoagulants. Viscoelastic coagulation was evaluated using ROTEM (INTEM, EXTEM, and FIBTEM assays). The primary outcome was all-cause mortality within 28 days after sepsis diagnosis. Associations between clinical, laboratory, and ROTEM parameters and mortality were examined using univariable analyses and prespecified multivariable logistic regression models. Model discrimination was assessed using the area under the receiver operating characteristic curve (AUC). Results: A total of 168 term neonates with sepsis were included, of whom 23 died within 28 days (mortality rate, 13.7%). Non-survivors had significantly higher nSOFA scores at diagnosis than survivors (median 12 vs. 6; Conclusion: Among term neonates with sepsis, early organ dysfunction severity assessed by nSOFA was the strongest determinant of short-term mortality. Non-survivors exhibited a consistent hypocoagulable phenotype characterized by prolonged conventional coagulation times, reduced clot strength, and impaired clot propagation on ROTEM. Although FIBTEM maximum clot firmness reflected disease severity and showed a clinically meaningful association with mortality, its incremental prognostic value beyond nSOFA and conventional coagulation measures was limited. ROTEM may therefore be most useful as a complementary tool for hemostatic phenotyping and assessment of coagulation dysfunction rather than as a stand-alone mortality prediction instrument. Larger multicenter studies incorporating serial viscoelastic assessments are warranted to further define its prognostic and clinical utility.