Sepsis in the neonate is a serious systemic infection that can be life-threatening, which happens in the first 28 days of life and is still one of the leading causes of neonatal morbidity and mortality in the world. It is especially common in low- and middle-income countries where there are poor maternal and child health facilities, long delays in diagnosis and care, and a lack of neonatal intensive care that result in poor neonatal outcomes. Neonatal infections contribute to a significant percentage of neonatal deaths worldwide, and sepsis is one of the main causes of neonatal deaths, according to the World Health Organization. Early recognition and timely treatment are therefore crucial to help increase the survival rate of the newborn and minimize complications [1,2]. Sepsis in neonates can be divided into two groups: early onset sepsis (EOS) and late onset sepsis (LOS). Sepsis, which occurs early, is typically present within the first 72 hours of life and is often associated with maternal and perinatal risk factors, including prolonged rupture of membranes, maternal fever, urinary tract infections, and poor hygiene during delivery. Late-onset sepsis typically begins more than 72 hours after birth, and is associated with hospital-acquired infections, invasive procedures, length of hospital stay, and poor infection control practices. If not treated swiftly, both types of sepsis can lead to serious complications such as septic shock, disseminated intravascular coagulation, respiratory failure, and meningitis, and may be fatal [3,4]. The clinical signs of neonatal sepsis are often nonspecific, and early diagnosis is difficult. Symptoms and signs are fever, hypothermia, lethargy, poor feeding, respiratory distress, jaundice, irritability, vomiting, abdominal distention, and convulsions. Laboratory studies of the complete blood count, C-reactive protein, blood culture, and CSF analysis are important to confirm the diagnosis. Blood culture continues to be the "gold standard" for detection of the causative organisms, but it is uncommon in clinical practice in the presence of antibiotic treatment and the limited sensitivity of the laboratory [5,6]. Several maternal and neonatal risk factors have been associated with neonatal sepsis. Immature immune function and extended hospital stay are the most important associated factors for poor outcomes in the newborn, including prematurity and low birth weight. Other maternal risk factors, such as PROM, fever in labour, uncooked pregnancies, and poor antenatal care, also play a large role in the incidence of neonatal infection. Gram-negative pathogens like Klebsiellae spp. and Escherichia coli are frequently isolated in developing countries, and other pathogens like Staphylococcus aureus and coagulase-negative staphylococci are also significant causative organisms for neonatal sepsis [7,8]. Neonatal sepsis remains a significant burden on health services despite the significant progress in the treatment of microbial infections and neonatal care. Evolving antimicrobial resistance poses further challenges for treatment and makes death more likely. Awareness of the clinical spectrum, risk factors, microbiology, and prognosis of neonatal sepsis helps in formulating appropriate preventive and management measures. High-risk neonates can be identified early, and evidence-based treatment protocols can make a huge difference in improving outcomes and reducing mortality rates [9]. This study aimed to evaluate the clinical features, risk factors for the mother and neonate, microbiological picture, and outcome of neonatal sepsis in neonates admitted to a tertiary care pediatric unit. The result of this study can be used to enhance early diagnosis, optimize healthcare approaches, and improve neonatal care services in tertiary healthcare centers [10].

Study Objectives

To identify the clinical profile, associated risk factors, microbiological patterns, and outcome of neonatal sepsis in neonates admitted to a tertiary care pediatric unit

Study Design & Setting

The cross-sectional study was carried out in the Department of Pediatrics Unit II, Sandeman Provincial Hospital (SPH), Quetta, Pakistan from 10 September 2025 to 10 Feb 2026  for six months.

Participants

The neonates aged 0-28 days who had been diagnosed with clinical or laboratory-confirmed neonatal sepsis were enrolled using a non-probability consecutive sampling method, which resulted in the recruitment of 100 neonates. Neonates who were admitted with signs and symptoms suggestive of sepsis (fever, not eating, difficulty breathing, listlessness, and/or positive septic screening) were enrolled upon informed consent of parents or guardians.

Sample Size Calculation

A sample size of 100 neonates was determined by applying the WHO sample size formula with the following parameters: desired confidence interval of 95%, error margin of 5%, and a prevalence of neonatal sepsis based on previous regional studies. The intended sample size allowed for the determination of clinical characteristics and outcomes with sufficient statistical precision.

Inclusion Criteria

• Neonates aged 0–28 days
• Neonatal sepsis – clinically suspected or laboratory confirmed
• Both male and female young
• Parents/guardians giving informed consent

Exclusion Criteria

• Infants at low birth weight (<5.5 pounds) weighing less than 5.5 pounds at birth
• Infants with metabolic diseases
• Patients discharged against medical advice
• Failure to report a complete history of medical tests or laboratory findings.Failure to report a complete history of medical tests or laboratory findings.

Diagnostic/Mgmt. Strategy

Clinical findings, septic screening, complete blood count, C-reactive protein, and blood culture reports were used to make a diagnosis. All neonates were started on empirical intravenous antibiotics, and culture-specific antibiotic treatment was according to hospital management protocol for neonatal sepsis.

Statistical Analysis

All data were input and analysed with SPSS version 26. The quantitative variables were age and duration of hospital stay, and were presented as mean ± SD. Frequency and Percentage were used to present categorical variables. The association between the risk factors and outcomes was assessed by using the chi-square test. A p-value of ≤0.05 was considered statistically significant

A total of 100 neonates with neonatal sepsis were included in the study. Among them, 58% were males and 42% were females, with a male-to-female ratio of 1.3:1. The mean age at presentation was 11.4 ± 6.2 days. Early-onset neonatal sepsis was observed in 62% of patients, while 38% had late-onset sepsis. Fever was the most common presenting complaint seen in 72% of neonates, followed by poor feeding in 65%, respiratory distress in 54%, lethargy in 49%, jaundice in 37%, vomiting in 22%, and seizures in 11% of cases. Prematurity was identified in 34% of neonates, and low birth weight was present in 41% of patients. Maternal risk factors included prolonged rupture of membranes in 29%, maternal fever in 18%, urinary tract infection during pregnancy in 14%, and uncooked pregnancies in 46% of cases. Blood cultures were positive in 39% of neonates. Klebsiella pneumoniae was the most frequently isolated organism accounting for 18% of positive cultures, followed by Staphylococcus aureus in 11% and Escherichia coli in 7% of cases. The mean hospital stay was 7.8 ± 3.5 days. Recovery was achieved in 82% of neonates, while 12% developed complications and mortality occurred in 6% of cases. Prematurity showed a statistically significant association with adverse outcomes (p=0.021). Low birth weight was significantly associated with prolonged hospital stay and increased complications (p=0.034). Mortality was significantly higher among culture-positive neonates compared to culture-negative cases (p=0.018).

Intervention Outcome

Empirical intravenous antibiotic therapy followed by culture-sensitive treatment resulted in clinical recovery in 82% of neonates. Complications were greatly reduced with early diagnosis and prompt management, and delays in presentation and/or prematurity were linked to worse outcomes and higher mortality.

Table 1: Demographic and Clinical Characteristics of Neonates with Sepsis (n=100)

Values are presented as frequencies and percentages of neonates diagnosed with neonatal sepsis.

Table 2: Maternal and Neonatal Risk Factors Associated with Neonatal Sepsis (n=100)

Maternal and neonatal factors identified among neonates admitted with clinical or laboratory-confirmed neonatal sepsis.

Table 3: Microbiological Profile of Neonatal Sepsis (n=100)

Blood culture results showing frequency and distribution of microorganisms isolated from septic neonates.

Table 4: Clinical Outcomes and Statistical Associations in Neonatal Sepsis (n=100)

Clinical outcomes and statistical associations of neonatal sepsis. A p-value ≤0.05 was considered statistically significant

Neonatal sepsis continues to be a significant cause of neonatal morbidity and mortality, especially in less-resourced countries, where infants are cared for in local hospitals with limited neonatal units. In the present study, clinical profile, associated risk factors, microbiological spectrum, and outcome of neonatal sepsis were evaluated in neonates admitted to a tertiary care pediatric hospital. Results showed that early-onset neonatal sepsis occurred more often than late-onset sepsis, with the clinical signs of fever, poor feeding, respiratory distress, and lethargy being the common clinical presentations. Poor clinical outcomes were significantly related to prematurity, low birth weight, and positive blood culture [11,12]. The neonatal sepsis in the present study showed male predominance, with 58% of males in the study population. This was in accordance with the other recent studies conducted by Sharma et al.  Khan et al. and Bhat et al. which reported a higher prevalence of male neonates. This could be due to differences between sexes in immunity that increase the susceptibility of male neonates to infections at this age [13]. In this study, the mean age at presentation was 11.4 ± 6.2 days, and of the 200 cases, 62% were early-onset neonatal sepsis (EONS). Similar findings were reported by Ahmed et al. and Gupta et al. who reported that the rates of early-onset sepsis had increased because of higher risk factors in the mother and the infant at the time of their birth. Vertical transmission of microorganisms from the mother during labour/delivery is a common cause of early-onset sepsis. These are substantiated by other factors identified in our study, such as maternal fever, prolonged rupture of membranes, and poor antenatal care [14,15]. In this study, the most frequent presentation symptoms are fever, poor feeding, and respiratory trouble. The same types of clinical patterns have been reported by Iqbal et al. Verma et Aland Siddiqui et al. [18]. Septicemia in the neonate frequently does not have a clear-cut clinical presentation and can be mistaken for other conditions. Thus, a high index of suspicion should be kept when neonates have subtle clinical presentations [16]. In the present study, among the neonatal risk factors, significant ones were related to prematurity and low birth weight. The neonates were also pre-term (34%) and low weight (41%). The results obtained are similar to those of Rafiq et al [17]. and Meena et al. who also reported that low birth weight and prematurity were the most important factors associated with poor neonatal outcomes. Neonates are at the greatest risk for severe infections due to their immature immune systems, lack of skin barrier function, and often need to be subjected to invasive procedures [18]. A total of 39% of neonates were found to be positive for blood culture, with Klebsiella pneumoniae being the leading organism, followed by Staphylococcus aureus. The bacteriological pattern was similar to that observed by Tariq et al. and Nisar et al [19]. who found that gram-negative bacteria were most common in neonatal intensive care units. This high frequency of gram-negative pathogens could be due to poor infection control measures, longer hospital duration, and the increased antimicrobial resistance observed in tertiary care hospitals [20]. In this study, the total recovery rate was 82%, and the neonatal mortality reported was 6%. Neonates who had positive blood cultures, were premature, and had low weight had significantly higher mortality. These results corroborate those of Ali et al. who found that the neonates with culture-positive sepsis and comorbid conditions had significantly worse outcomes. The relatively good recovery rate in our study may be due to early diagnosis, prompt treatment with empirical antibiotics, and better neonatal intensive care services [21,22]. This study reiterates the ongoing burden of neonatal sepsis in tertiary care hospitals and therefore underscores the significance of maternal healthcare, infection prevention, early detection, and prompt management in neonatal sepsis. Improved antenatal care, proper sterile delivery practices, and tailored and evidence-based neonatal sepsis protocols could drastically cut neonatal morbidity and mortality in resource-poor areas [23].

Limitations

The study was carried out in a single tertiary care centre, and the number of neonates was small (100), which may restrict the generalizability of the results. Long-term outcomes of neonates and antibiotic resistance were not well assessed. Also, there may have been some cases of culture-negative sepsis that have influenced the accuracy of the microbiological assessment,

Neonatal sepsis continues to be a major cause of neonatal morbidity and mortality. Early-onset sepsis was more prevalent, and low birth weight, culture-positive infections, and prematurity were associated with poor outcomes. Early diagnosis, early treatment with antibiotics, and better maternal and newborn health services are critical to minimize complications and save lives for newborn babies.

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