Magnitude, Bacteriological Profile, and Antimicrobial Susceptibility Pattern of Neonatal Sepsis in Neonates Admitted to NICU of Menelik II Comprehensive Specialized Hospital, Addis Ababa, Ethiopia.

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Abstract Background: Neonatal sepsis is a systemic infection caused by bacterial, viral, or fungal pathogens, characterized by hemodynamic instability and clinical signs in infants younger than 28 days of age. It remains a significant cause of morbidity and mortality among infants, particularly in middle- and lower-income countries. Neonatal sepsis can be classified into early-onset sepsis (which occurs within the first 0 to 3 days after birth) and late-onset sepsis (which arises after the first three days of life). Effective treatment for neonatal sepsis, therefore, requires identifying pathogens, including both gram-positive and gram-negative bacteria, and understanding the patterns of antimicrobial resistance associated with these organisms. Objective: The overall objective of this study is to determine the magnitude, bacteriological profile, and antimicrobial susceptibility patterns of neonatal sepsis, and to assess clinical outcomes and associated factors among neonates admitted to the NICU of Menelik II Comprehensive Specialized Hospital, Addis Ababa, Ethiopia. Methods: An institution-based cross-sectional study was conducted among 251 neonates admitted to the NICU between June and December 2024 using a consecutive sampling technique. Blood samples (1-2 ml) were collected for bacterial culture and antimicrobial susceptibility testing. Data were analyzed using descriptive statistics, bivariate, and multivariable analyses to identify significant associations. Associations were reported with odds ratios and 95% confidence intervals; p < 0.05 was considered statistically significant. Result: A total of 251 neonates clinically suspected of sepsis were included in the study, with a mean age of 5.43 (SD ± 6.41) days, ranging from 1 to 28 days. Of these, 59% were due to early onset sepsis and 41% to late-onset sepsis. The overall culture confirmed neonatal sepsis was 114(45.4%) (95% CI: 39.4, 51.4), with 59.6% by Gram-negative bacteria and 40.4% caused by Gram-positive. Gram-negative bacteria showed high susceptibility to Piperacillin-Tazobactam (100%), Amikacin (90.8%), Meropenem (80%), and Imipenem (78.5%), but high resistance to Ceftriaxone (62%) and Trimethoprim-Sulfamethoxazole (48.2%). Notably, Gram-positive bacteria were highly resistant to Oxacillin (76%) and Penicillin (77%). Regarding clinical outcomes, 78.1% neonates were discharged home while the overall mortality rate was 13.5% (34/251; 95% CI: 9.7 17.9). The majority of deaths (79.4%) occurred in early-onset cases. Among the neonates who died, 18 (52.9%) had culture-confirmed sepsis; of these, 88.9% were caused by Gram-negative bacteria, and 33.3% were attributable to Klebsiella spp. Late neonatal age (AOR 2.19) (95% CI: 1.25, 3.82), neonates experiencing respiratory distress (AOR 3.44) (95% CI: 1.19, 9.93), and co symptoms ( AOR 5.22) (95% CI: 1.69, 16.10) were significantly associated with higher neonatal sepsis. Conclusion: The study revealed a high prevalence of neonatal sepsis, with Gram-negative bacteria being the dominant etiology and demonstrating alarming resistance to first-line antibiotics. A considerable mortality rate was observed, particularly among cases of early-onset sepsis and Gram-negative infections. Therefore, urgent revision of current empirical antimicrobial guidelines and continuous, active surveillance are critical to improve clinical outcomes and reduce neonatal mortality. Keywords: neonatal sepsis, antimicrobial susceptibility, bacterial profile

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