Clinical Profile and Outcomes of Neonatal Sepsis in a Level-III Neonatal Intensive Care Unit: A Prospective Observational Study

Abstract

Background: Neonatal sepsis remains a major cause of neonatal mortality in low- and middle-income countries. Up-to-date data on clinical profile, aetiological agents, antimicrobial susceptibility and outcomes from Indian level-III neonatal intensive care units (NICUs) are essential to guide local empirical therapy and infection-prevention practice. This study characterized the clinical features, microbiological spectrum, antimicrobial resistance patterns and outcomes of neonatal sepsis in a tertiary-care NICU. Methods: A single-centre, prospective observational study was conducted between January 2024 and December 2025. All neonates admitted to a level-III NICU with clinical and/or cultureproven sepsis were enrolled (n = 210). Demographic, perinatal, clinical and laboratory data were systematically collected. Blood cultures were processed using the BACTEC system. Outcomes assessed included in-hospital mortality, length of stay and major morbidities. Results: Of 210 neonates, 124 (59.0%) had early-onset sepsis (EOS) and 86 (41.0%) had late-onset sepsis (LOS). Blood culture positivity was 32.9% (69 of 210). Gram-negative organisms predominated (60.9%), led by Klebsiella pneumoniae (24.6%), Acinetobacter species (15.9%) and Escherichia coli (11.6%). Among Gram-positive isolates, coagulasenegative staphylococci (15.9%) and Staphylococcus aureus (10.1%) were most common. Multidrug resistance was observed in 56.5% of Gram-negative isolates. Overall in-hospital mortality was 18.6%, significantly higher in culture-positive than culture-negative sepsis (29.0% vs 13.5%; p = 0.007). Mortality was associated with prematurity, very low birth weight, mechanical ventilation and multidrug-resistant Gram-negative infection. Conclusion: Neonatal sepsis in this Indian level-III NICU was driven predominantly by multidrug-resistant Gram-negative organisms, with substantial mortality. Strengthening infection prevention, antimicrobial stewardship and timely microbiological diagnosis are urgent priorities for improving neonatal outcomes.