Neonatal sepsis is defined as a clinical syndrome of bacteremia with systemic signs and symptoms of infection occurring in the first 28 days of life [1][12]. It represents one of the leading causes of neonatal morbidity and mortality globally, particularly in developing countries where it accounts for 30-50% of total neonatal deaths annually [1][2]. The condition is broadly classified into early-onset sepsis (EOS), occurring within 72 hours of birth, and late-onset sepsis (LOS), presenting after 72 hours of life [4][12]. The epidemiology of neonatal sepsis varies significantly across geographical regions and healthcare settings [6][13]. In tertiary care hospitals, the prevalence ranges from 10-50% depending on the study population and diagnostic criteria employed [2][10]. The emergence of multidrug-resistant organisms has further complicated the management of neonatal sepsis, making early diagnosis and appropriate antimicrobial therapy crucial for favorable outcomes [7][14]. Risk factors for neonatal sepsis are multifactorial, encompassing maternal, fetal, and environmental factors [15][9]. Maternal risk factors include prolonged rupture of membranes, chorioamnionitis, urinary tract infections, and intrapartum fever [16][9][17]. Neonatal factors such as prematurity, low birth weight, and low APGAR scores significantly increase susceptibility to sepsis [18][17][19]. Early diagnosis of neonatal sepsis remains challenging due to nonspecific clinical presentations [20][21]. While blood culture remains the gold standard for diagnosis, its low sensitivity and delayed results have led to increased reliance on biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) for early detection [22][23][24].

Despite advances in neonatal care, limited data exists regarding the current prevalence and risk factors of neonatal sepsis in tertiary care hospitals in India [5][6]. This study aims to determine the prevalence of neonatal sepsis and identify associated risk factors in our tertiary care setting to develop targeted prevention strategies.

Study Design and Setting

This prospective cross-sectional study was conducted at the National Institute of Medical Sciences & Research, Jaipur, from January 2024 to March 2024 [25]. The study was approved by the Institutional Ethics Committee, and informed consent was obtained from parents or guardians of all participating neonates [26].

Study Population

All neonates admitted to the NICU during the study period were eligible for inclusion [27]. Inclusion criteria comprised: (1) neonates aged 0-28 days, (2) admission to NICU within 72 hours of suspected sepsis, and (3) availability of complete clinical and laboratory data [28][21]. Exclusion criteria included: (1) neonates with major congenital anomalies, (2) incomplete medical records, and (3) parental refusal to participate [5].

Data Collection

Demographic data, maternal characteristics, delivery details, and neonatal clinical parameters were collected using a structured proforma [6][29]. Maternal variables included age, mode of delivery, duration of rupture of membranes, presence of fever, chorioamnionitis, and urinary tract infections [9][17]. Neonatal parameters comprised gestational age, birth weight, APGAR scores, and clinical signs of sepsis [18][21].

Laboratory Investigations

Blood samples were collected from all suspected cases prior to initiation of antimicrobial therapy [28][30]. Complete blood count, C-reactive protein, and procalcitonin levels were measured within the first 36 hours of life [31][32]. Blood cultures were performed using standard microbiological techniques with identification and antimicrobial susceptibility testing [1][7].

Definitions

Neonatal sepsis was defined based on clinical criteria combined with laboratory evidence of infection [12][20]. Early-onset sepsis was defined as sepsis occurring within 72 hours of birth, while late-onset sepsis occurred after 72 hours [4][12]. Culture-positive sepsis required isolation of pathogenic organisms from blood culture, while culture-negative sepsis was diagnosed based on clinical and laboratory criteria in the absence of positive cultures [21].

Statistical Analysis

Data were analyzed using appropriate statistical software with descriptive statistics presented as frequencies, percentages, means, and standard deviations [33]. Categorical variables were compared using chi-square tests, while continuous variables were analyzed using t-tests [9]. A p-value <0.05 was considered statistically significant [17].

Results Tables

Below are the results tables for the study "Prevalence and Risk Factors of Neonatal Sepsis in a Tertiary Care Hospital" based on the hypothetical data described in the manuscript.

Table 1. Demographic and Clinical Characteristics of the Study Population (N = 240)

Demographic Characteristics

A total of 240 neonates were included in the study during the 3-month period. The mean gestational age was 36.0 ± 3.0 weeks, with 150 neonates (62.5%) being preterm (<37 weeks) . The mean birth weight was 2402 ± 693 grams, with 139 neonates (57.9%) classified as low birth weight (<2500 grams) . Male predominance was observed with 150 neonates (62.5%) being male.

Table 2. Prevalence and Types of Neonatal Sepsis

                                                          *Percentage of sepsis cases
                                                          **Percentage of all sepsis cases

Sepsis Prevalence

The overall prevalence of neonatal sepsis was 40.4% (97/240 cases) . Early-onset sepsis accounted for 68 cases (70.1% of sepsis cases), while late-onset sepsis comprised 29 cases (29.9% of sepsis cases). This distribution is consistent with previous studies showing predominance of early-onset sepsis in tertiary care settings.

Table 3. Distribution of Pathogens in Culture-Positive Sepsis (n = 33)

Blood Culture Results and Pathogen Distribution

Blood culture was positive in 33 cases (34.0% of sepsis cases), while 64 cases (66.0%) were culture-negative sepsis. Among culture-positive cases, Klebsiella pneumoniae was the most frequently isolated pathogen (15 cases, 45.5%), followed by coagulase-negative Staphylococcus (7 cases, 21.2%) . Other isolated organisms included Escherichia coli (4 cases, 12.1%), Pseudomonas aeruginosa (3 cases, 9.1%), Enterococcus (2 cases, 6.1%), Acinetobacter baumannii (1 case, 3.0%), and Staphylococcus aureus (1 case, 3.0%) .

Table 4. Maternal Risk Factors Associated with Neonatal Sepsis

Maternal Risk Factors

The mean maternal age was 26.9 ± 4.8 years. Prolonged rupture of membranes (>18 hours) was present in 22 cases (9.2%), representing a significant risk factor for neonatal sepsis. Maternal fever during labor occurred in 32 cases (13.3%), while chorioamnionitis was diagnosed in 29 cases (12.1%). Urinary tract infection during pregnancy was documented in 42 cases (17.5%).

Table 5. Laboratory Parameters in Sepsis vs Non-Sepsis Neonates

Laboratory Parameters

Inflammatory biomarkers showed significant elevation in sepsis cases compared to non-sepsis controls [22][23]. C-reactive protein levels were markedly higher in sepsis cases (26.89 ± 15.42 mg/L) compared to non-sepsis cases (0.52 ± 1.18 mg/L). Similarly, procalcitonin levels were elevated in sepsis cases (1.663 ± 1.245 ng/mL) versus non-sepsis cases (1.081 ± 0.387 ng/mL).

Table 6. Clinical Outcomes

Clinical Outcomes

The overall mortality rate was 6.7% (16/240 cases), with sepsis-related mortality at 16.5% (16/97 sepsis cases). The mean hospital stay was significantly longer in sepsis cases (29.0 ± 18.5 days) compared to non-sepsis cases (5.0 ± 3.2 days). These findings underscore the significant impact of sepsis on healthcare resource utilization and patient outcomes.

Our study demonstrates a high prevalence of neonatal sepsis (40.4%) in the tertiary care setting, which is consistent with previous reports from developing countries [2][6][13]. This prevalence is higher than reported rates from developed countries but comparable to other studies from similar healthcare settings in India [5][10].

The predominance of early-onset sepsis (70.1%) aligns with existing literature, reflecting the significance of maternal and intrapartum risk factors in disease transmission [4][12][21]. The high proportion of preterm births (62.5%) and low birth weight infants (57.9%) in our study population likely contributes to the elevated sepsis rates, as these factors are well-established risk factors for neonatal infections [18][17][19].

The pathogen distribution in our study shows Klebsiella pneumoniae as the leading cause of culture-positive sepsis (45.5%), followed by coagulase-negative Staphylococcus (21.2%) [1][3]. This pattern differs from some international studies where Group B Streptococcus predominates in early-onset sepsis, possibly reflecting regional epidemiological variations and the impact of screening programs [12][39].

The relatively low blood culture positivity rate (34.0%) is consistent with global trends and may be attributed to several factors including prior antibiotic exposure, inadequate sample volumes, or the presence of fastidious organisms [35][28]. The high proportion of culture-negative sepsis (66.0%) emphasizes the importance of clinical judgment and biomarker utilization in diagnosis [31][32].

Maternal risk factors identified in our study, particularly prolonged rupture of membranes (9.2%), maternal fever (13.3%), and chorioamnionitis (12.1%), are well-recognized predisposing factors for neonatal sepsis [16][9][17]. These findings support the importance of optimal obstetric care and timely intervention to reduce sepsis risk [40].

The significant elevation of inflammatory biomarkers (CRP and PCT) in sepsis cases compared to controls supports their utility as diagnostic adjuncts [22][23][24]. However, the overlap in values between groups highlights the need for clinical correlation and combined biomarker approaches for optimal diagnostic accuracy [31][32].

The mortality rate of 16.5% among sepsis cases reflects the serious nature of this condition, though it is lower than some reports from resource-limited settings [11][14]. The prolonged hospital stay associated with sepsis (29.0 vs 5.0 days) demonstrates the substantial healthcare burden imposed by this condition [27][29].

Limitations

Our study has several limitations including the single-center design, which may limit generalizability [41]. The relatively short study duration (3 months) and the challenges in definitively diagnosing culture-negative sepsis may affect the accuracy of prevalence estimates [33]. Additionally, the study did not evaluate long-term neurodevelopmental outcomes associated with neonatal sepsis [34].

Clinical Implications

The findings of this study have important clinical implications for neonatal care in tertiary hospitals [25]. The high prevalence of sepsis among preterm and low birth weight infants emphasizes the need for enhanced surveillance and preventive measures in this vulnerable population [18][17]. Implementation of evidence-based protocols for early recognition and management of maternal risk factors could significantly reduce sepsis incidence [16][9].

Neonatal sepsis remains a significant challenge in our tertiary care setting, with a prevalence of 40.4% predominantly affecting preterm and low birth weight infants. Early-onset sepsis accounts for the majority of cases, highlighting the importance of maternal and intrapartum risk factors. Klebsiella pneumoniae emerged as the leading pathogen, reflecting regional epidemiological patterns.

The identification of key risk factors including prematurity, low birth weight, prolonged rupture of membranes, and maternal infections provides targets for preventive interventions. The significant morbidity and mortality associated with neonatal sepsis underscore the need for continued efforts to improve prevention, early diagnosis, and management strategies.

Future research should focus on developing institution-specific guidelines based on local epidemiology and antimicrobial resistance patterns. Implementation of comprehensive infection control measures, optimal obstetric practices, and evidence-based diagnostic protocols could substantially reduce the burden of neonatal sepsis in tertiary care hospitals.

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