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Life sciences · Observational Study
ClinicalTrials.gov · September 22, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06058819). This is a study registration, not published results. Lead sponsor: Hospices Civils de Lyon. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 285 participants (ESTIMATED). Conditions: Neonatal Late Onset Sepsis. Interventions: DIAGNOSTIC_TEST: Newborns suspected of Infections. Primary outcome measures: Diagnosis of late onset sepsis , 72 hours maximum after inclusion. Brief summary: Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments). Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be related to other neonatal conditions such as prematurity and birth defects, are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity. This explains why excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality. A previous study (EMERAUDE) aimed to identify new biomarkers to early exclude the diagnosis of LOS, in order to limit antibiotic overuse. This study including 230 neonates revealed high performances of IL6, IL10, NGAL and combinations of PCT/IL10 and PTX3/NGAL. The main objective of the present study will be to validate the performances of these biomarkers in another cohort. The secondary objectives will be to explore transcriptomic biomarkers and salivary biomarkers.