Clinical and Microbiological Profile of Culture-Positive Neonatal Sepsis in a Tertiary Care Center in North India

Background Sepsis in newborns is a major clinical concern, especially in resource-limited settings. Although blood culture remains the primary method for confirming infection and guiding treatment, its detection rate is often suboptimal. The objective of this study was to evaluate the incidence, clinical characteristics, maternal and neonatal risk factors, and antimicrobial resistance patterns linked to culture-confirmed neonatal sepsis in a tertiary care facility in North India. Materials and methods This prospective observational study was carried out over 18 months in the neonatal intensive care unit (NICU) of Hind Institute of Medical Sciences, a tertiary care teaching hospital in Sitapur, India, enrolling 118 neonates aged 28 days or younger who presented with clinical signs suggestive of sepsis. Data on maternal and neonatal risk factors were collected using a pre-tested proforma. Blood cultures were processed using standard microbiological techniques, and antibiotic susceptibility was assessed. Statistical analysis was performed using IBM SPSS Statistics version 26.0. Significant risk factors associated with culture-positive sepsis were identified using binary logistic regression analysis. Results Among 118 neonates, 28% (33/118) had culture-positive sepsis. Klebsiella pneumoniae (13/33, 39.4%), Staphylococcus aureus (9/33, 27.3%), and Escherichia coli (6/33, 18.2%) were the predominant isolates. Most pathogens exhibited resistance to ampicillin and third-generation cephalosporins, while retaining sensitivity to meropenem and amikacin. Significant neonatal risk factors included low birth weight (<2500 g; odds ratio (OR) = 7.179; p < 0.001), resuscitation at birth (OR = 4.222; p = 0.005), positive sepsis screen (OR = 12.03; p < 0.001), and prolonged hospital stay (>7 days; OR = 20.844; p < 0.001). Significant maternal predictors included preterm delivery (OR = 15.80; p < 0.001), premature rupture of membranes ≥18 hours (OR = 4.80; p < 0.001), maternal fever (OR = 5.213; p < 0.001), foul-smelling liquor (OR = 4.875; p = 0.001), ≥3 per vaginal examinations (OR = 4.168; p = 0.001), and cesarean delivery (OR = 3.503; p = 0.004). The sepsis screening test demonstrated a sensitivity of 84.8% and a negative predictive value of 92.1%. Conclusion Neonatal sepsis continues to impose a significant clinical burden, with high rates of early-onset sepsis and multidrug-resistant gram-negative organisms. Identification of key maternal and neonatal risk factors may aid early diagnosis and improve outcomes. Strengthening microbiological surveillance and antimicrobial stewardship is essential to combat rising resistance and reduce neonatal mortality.