Neonatal sepsis is an infection involving the bloodstream in infants under 28 days old. It remains a leading cause of morbidity and mortality among neonates, especially in middle and lower- income countries [1]. Neonatal sepsis is divided into 2 groups based on the time of presentation after birth: early-onset sepsis (EOS) and late-onset sepsis (LOS). EOS refers to sepsis in neonates at or before 72 hours of life (some experts use 7 days), and LOS is defined as sepsis occurring at or after 72 hours of life [2]. In high-income settings, early-onset sepsis (EOS) typically occurs in approximately 0.5–1.0 per 1,000 live births, while late-onset sepsis (LOS) rates are markedly higher among hospitalized preterm/VLBW infants; in many LMICs, both EOS and LOS rates are several-fold higher due to challenges in peripartum infection prevention, limited access to timely care, and antimicrobial resistance (AMR) [3-4]. The maternal vaginal tract is typically the site of infection in EOS, which can lead to ascending infection and colonization of the newborn. Bacterial agents can also spread vertically during pregnancy or, more frequently, during childbirth. Group B Streptococcus, E. coli, Klebsiella, and Enterobacter species are the germs that cause the EOS [5]. Either nosocomial or community-acquired infections are the cause of LOS. Coagulase-negative organisms have been linked to LOS. Pseudomonas, Enterobacter, Klebsiella, Staphylococci, Staphylococcus aureus, E. Coli, and anaerobes [6]. Low birth weight (<2500 grams), Prematurity, Febrile illness in the mother within two weeks prior to delivery, Foul smelling liquor amnii, Prolonged rupture of membranes >18 hours, more than three vaginal examinations during labour, prolonged and difficult delivery with instrumentation, perinatal asphyxia (APGAR score <4 at 1 minute of age) or difficult resuscitation were the common risk factors for EOS [7]. Staying in an intensive care unit, not receiving enteral feedings for an extended period of time, having an indwelling catheter, or receiving total parenteral nutrition (TPN) are all risk factors for LOS [8]. Neonatal sepsis has mild clinical indications, and it is frequently challenging to diagnose the condition based only on clinical findings. Despite its 50–80% sensitivity, blood cultures are still the gold standard for detecting sepsis [9]. A definitive diagnosis is based on culture reports which are not available for at least two days. Therefore, a sepsis screen that includes additional tests such as total leukocyte count, absolute neutrophil count, micro-ESR (erythrocyte sedimentation rate), immature to total neutrophil ratio, and C-reactive protein (CRP) has been suggested by several authors to improve the diagnostic accuracy [10-11]. Neutropenia and increased prothrombin time are independent predictors of mortality in neonatal sepsis [12]. Aims and objectives: This study has tried to determine the incidence, evaluates various risk factors and clinical presentations of fatal neonatal septicemia in a tertiary care hospital, India.

Study design and setting: This was a Hospital-based prospective observational study conducted in the department of pediatrics (neonatal intensive care unit) at Shri Shankaracharya Institute of Medical Sciences, Bhilai, Dist. Durg, Chhattisgarh and Shri balaji institute of medical science, Raipur Chhattisgarh, India. Study population: All live-born infants delivered at or admitted to our hospitals during the study period were screened daily for Early or late onset sepsis signs. Inclusion criteria: • All live-born neonates delivered at, or admitted in our hospital during study period and not received prior antibiotics. • Whose parents or guardians provided written informed consent for study Exclusion criteria: • Major congenital anomalies incompatible with life • Neonates who died before clinical assessment or before specimen collection • Readmissions beyond 28 days of life • Babies delivered outside our institutions and received antibiotics before collection of samples. • Whose parents or guardians not provided consent for study Case definitions and classification • Suspected neonatal sepsis: any neonate with at least one of the following: temperature instability (≥38.0°C or <36.0°C), respiratory distress or apnea, feeding intolerance, lethargy or irritability, hypotonia, tachycardia or bradycardia, capillary refill >3 seconds, hypotension, hypoglycemia/hyperglycemia, seizures, or need for escalation of care. • Confirmed (culture-positive) sepsis: isolation of a pathogenic organism from blood culture obtained before initiation of systemic antibiotics, with compatible clinical signs. Classified as pathogens only if two separate cultures are positive with compatible clinical context or at clinician consensus per predefined algorithm. • Probable (culture-negative) sepsis: clinical signs plus ≥2 abnormal laboratory markers (e.g., CRP ≥10 mg/L, procalcitonin ≥0.5 ng/mL, WBC <5 or >20 ×10^9/L, ANC <1.5 ×10^9/L, I:T ratio >0.2, platelets <150 ×10^9/L) and a documented antimicrobial treatment course ≥5 days. • Early-onset sepsis (EOS): onset of symptoms ≤72 hours of life. • Late-onset sepsis (LOS): onset of symptoms >72 hours to 28 days of life. Clinical assessment and data collection: A thorough prenatal history and demographics were obtained for every newborn exhibiting clinical signs of sepsis. The parents were questioned about the birth weight, the technique and location of delivery, and potential risk factors for developing sepsis. A thorough clinical examination was performed. All aseptic procedures were followed when collecting blood samples. In every instance, blood culture, CRP, PCT, blood sugar, serum electrolytes, total blood count, band cell count, and prothrombin time were performed. Additional tests, such as lumbar punctures, chest x-rays, and urine analysis, were performed when needed. To ascertain the ultimate result, the neonates were monitored. Statistical analysis: Data were analyzed using appropriate statistical software with descriptive statistics presented as frequencies, percentages, means, and standard deviations. Categorical variables were compared using chi-square tests, while continuous variables were analyzed using t-tests. A p-value <0.05 was considered statistically significant

Out of 1000 live births, 115 neonates (11.5%) were clinically suspected to have sepsis. Among them, 37 neonates (3.7%) had culture-proven septicemia. Of these confirmed cases, 25 (67.9%) were early-onset sepsis (EOS), and 12 (32.1%) were late- onset sepsis (LOS). Table 1: Incidence of Neonatal Septicemia among study neonates Parameter Number (n) Percentage (%) Total live births during study period 1000 100 Suspected sepsis cases 115 11.5 Blood culture positive (confirmed sepsis) 37 3.7 Early-onset sepsis (≤72 hrs) 25 67.9 Late-onset sepsis (>72 hrs) 12 32.1 Table 2 describes the association between various maternal risk factors and the occurrence of neonatal septicemia. These findings indicate that adverse maternal intrapartum and antenatal conditions significantly increase the risk of neonatal septicemia. Mode of delivery (LSCS) did not show a significant association (p = 0.32). Table 2: Maternal Risk Factors Associated With Neonatal Septicemia Maternal Risk Factor Septicemia Present (n=37) No Septicemia (n=963) p-value Maternal fever during labor 13 (35.2%) 145 (15.1%) <0.001 PROM >18 hrs 16 (43.3%) 194 (20.2%) <0.001 Meconium-stained liquor 9 (24.3%) 118 (12.3%) 0.002 UTI during pregnancy 8 (21.6%) 109 (11.3%) 0.001 Inadequate antenatal visits 22 (59.5%) 403 (41.8%) 0.004 Mode of delivery – LSCS 12 (32.4%) 350 (36.3%) 0.32 Table 3 highlights the neonatal characteristics that were significantly associated with septicemia. These findings suggest that physiologically vulnerable neonates—especially preterm and low- birth-weight infants—are at higher risk of developing septicemia. Table 3: Neonatal Risk Factors Associated With Neonatal Septicemia Neonatal Factor Septicemia Present (n=37) No Septicemia (n=963) p-value Low birth weight (<2500 g) 20 (54.1%) 248 (25.7%) <0.001 Preterm (<37 weeks) 17 (45.9%) 215 (22.3%) <0.001 Birth asphyxia 9 (24.3%) 89 (9.2%) <0.001 Need for resuscitation 9 (24.3%) 113 (11.7%) 0.001 Male sex 23 (62.2%) 479 (49.7%) 0.01 Poor feeding (71.5%), Respiratory distress (58.1%) and Lethargy (50.3%) are the most common clinical symptoms. Temperature instability, seizures, jaundice, and abdominal distension were also present but to a lesser extent. The most common pathogen isolated from neonatal septicemia cases were: Klebsiella pneumoniae (31.5%) Followed by E. coli (23%), Staphylococcus aureus (17.6%), Coagulase- negative staphylococci (CONS) (14.5%) and Pseudomonas species (7.3%) Table 4: Blood Culture Profile of Neonatal Septicemia Organism Isolated Number (n=37) Percentage (%) Klebsiella pneumoniae 12 31.5 E. coli 9 23.0 Staphylococcus aureus 7 17.6 Coagulase-negative staphylococci (CONS) 5 14.5 Pseudomonas 3 7.3 Others 2 6.1 A majority of neonates improved and were discharged. Mortality was 10.9%, reflecting the severity of neonatal sepsis despite treatment.

In the present study, the incidence of neonatal septicemia was 3.7%, which is comparable with findings from other Indian tertiary-care centers. Similar incidence (3–5%) has been reported by Jyothi et al [13] and Mathur et al [14], indicating that neonatal sepsis continues to be a significant cause of morbidity in developing countries. A higher proportion of cases belonged to early-onset sepsis, suggesting that maternal and perinatal factors play a crucial role in disease transmission. This aligns with the observations of Sharma et al [15], who also highlighted the predominance of EOS in South Asian populations. In the present study, among maternal factors, PROM >18 hrs, maternal fever during labor, and UTI were significantly associated with neonatal sepsis. These findings are consistent with earlier studies by Mondal et al [16] and Bizzarro et al [17], which established PROM, maternal infection, and intrapartum fever as major contributors to early neonatal infections. Additionally, inadequate antenatal visits emerged as a risk factor, reflecting gaps in antenatal surveillance and timely management of maternal infections. We have observed that the low birth weight and prematurity were strongly associated with septicemia in this study. These results corroborate the findings of Stoll et al [18], who documented that preterm and LBW neonates have impaired immunity, making them more susceptible to invasive infections. Birth asphyxia and need for resuscitation were also significant predictors, as previously reported by Thaver & Zaidi, et al [19]. In our study the most common clinical manifestations were poor feeding, respiratory distress, and lethargy. These nonspecific symptoms are consistent with those reported in multiple studies, including Edwards et al [20] and Singh S, et al [21], highlighting the diagnostic difficulty due to vague presentations. Fever and hypothermia were noted in 25.4% and 23.6% of cases, respectively, reaffirming the wide temperature instability observed in septic neonates. Current study reported that the Klebsiella pneumoniae was the most common organism isolated, followed by E. coli and Staphylococcus aureus. This predominance of Gram-negative organisms mirrors the findings of F. B. Al Bakoush et al [22] and Roy et al [23], which emphasize the emergence of multidrug-resistant Gram-negative bacilli in Indian NICUs. The mortality rate of 10.9% in this study is slightly lower than values historically reported (12– 18%), suggesting improved early diagnosis and management. However, the mortality remains significant, underscoring the need for strengthening infection control practices, antenatal care, and timely neonatal resuscitation. Overall, the findings of the present study align with national and international literature and reinforce the importance of risk-factor identification, early diagnosis, and prompt treatment to reduce sepsis-related neonatal mortality.

Neonatal septicemia continues to be a major cause of morbidity and mortality, with an incidence of 3.7% in the present study. Early-onset sepsis predominated, highlighting the strong influence of maternal and perinatal factors, including PROM, maternal fever, and UTI. Neonatal factors such as prematurity, low birth weight, birth asphyxia, and need for resuscitation significantly increased the risk of sepsis. The most common clinical features poor feeding, respiratory distress, and lethargy were nonspecific, underscoring the need for high clinical suspicion. Klebsiella pneumoniae emerged as the predominant pathogen, consistent with trends observed in Indian NICUs. Despite improvements in management, sepsis-related mortality remains a challenge. Strengthening antenatal care, improving delivery practices, and ensuring strict infection control can significantly reduce the burden of neonatal septicemia. Early identification of at-risk neonates and timely intervention remain key to improving outcomes.

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