Background: Early-onset neonatal sepsis (EONS) remains a significant cause of neonatal morbidity and mortality, particularly in resource-limited settings. EONS is defined as sepsis occurring within 72 hours of birth, often associated with maternal risk factors such as premature rupture of membranes and intrapartum infections. Identifying risk factors and improving early diagnosis are critical to reducing adverse outcomes in neonates. Objective: This study aimed to assess the incidence, microbial profile, cutaneous manifestations, risk factors, and diagnostic accuracy of early-onset neonatal sepsis (EONS) in a large urban hospital. Methods: A retrospective cohort study was conducted at the Neonatal Intensive Care Unit (NICU) of a large urban hospital in Khammam. The study included 100 neonates admitted within 72 hours of birth between January and December 2023. EONS was diagnosed based on clinical suspicion and confirmed by blood cultures and laboratory markers. Data collection included demographic, clinical, and maternal risk factors. Multivariable logistic regression identified significant risk factors for EONS, while receiver operating characteristic (ROC) curve analysis assessed diagnostic accuracy. Results: Eighteen neonates (18%) were diagnosed with EONS, with Escherichia coli being the most common pathogen (44%). Significant risk factors included premature rupture of membranes (OR = 4.3, p = 0.001), maternal intrapartum fever (OR = 2.8, p = 0.03), and low Apgar scores. The ROC curve for the diagnostic model showed strong accuracy (AUC = 0.85, 95% CI: 0.78-0.92). Conclusion: EONS remains a prevalent issue in urban NICUs, with identifiable risk factors and microbial profiles. Early identification through clinical and maternal markers can significantly improve outcomes.
Early-onset neonatal sepsis (EONS) remains a significant challenge in neonatal care, contributing to substantial morbidity and mortality worldwide1. Defined as sepsis occurring within the first 72 hours of life, EONS poses a considerable threat to neonatal health, particularly in preterm and low birth weight infants2,3. Despite advances in medical care, the incidence of EONS and its associated complications persist, necessitating ongoing research to elucidate its epidemiology, risk factors, and optimal management strategies4,5.
Several risk factors have been implicated in the development of EONS, including maternal infections, premature rupture of membranes, and invasive procedures during delivery6. Additionally, the microbial profile of EONS has evolved over time, with varying prevalence rates of different pathogens in different geographic regions and clinical settings. Understanding the microbial etiology and associated risk factors is crucial for guiding empirical antibiotic therapy and implementing preventive measures to reduce the incidence of EONS7.
In urban hospital settings, where a diverse patient population is served, the epidemiology of EONS may differ from that in other healthcare settings. Factors such as population density, socioeconomic status, and access to healthcare services can influence the incidence and outcomes of EONS in urban neonatal populations8. Therefore, comprehensive studies conducted in large urban hospitals are essential for characterizing the burden of EONS and informing targeted interventions to improve neonatal outcomes.
Aim and Objectives
To investigate the trends, risk factors, and microbial profiles associated with early-onset neonatal sepsis in a large urban hospital, aiming to enhance early diagnosis, management, and prevention strategies.
Trend Analysis: Assess the incidence rate of early-onset neonatal sepsis over time to identify shifts or patterns comparing current and historical data.
Risk Factor Identification: Evaluate and quantify significant risk factors like premature rupture of membranes, maternal fever, mode of delivery, and low Apgar scores using odds ratios.
Microbial Profiling: Delineate the microbial agents responsible for sepsis, focusing on the prevalence of pathogens such as Escherichia coli, Group B Streptococcus, and Staphylocoxccus aureus.
Geographic and Demographic Assessment: Examine the influence of geographic and demographic factors on sepsis incidence, analyzing differences between urban and suburban neonates.
By identifying key determinants of EONS and trends over time, our findings contribute to the existing knowledge base and provide knowledge for optimizing neonatal care practices in urban healthcare settings.
Study Design:
This retrospective cohort study was conducted to assess the incidence, microbial profile, cutaneous manifestations, and risk factors of early-onset neonatal sepsis (EONS) at a large urban hospital.
Setting:
The study was performed in the Neonatal Intensive Care Unit (NICU) of a mamata hospital in Khammam. The hospital is well-equipped with comprehensive neonatal care facilities and handles a high volume of annual births.
Participants:
The study involved 100 neonates admitted to the NICU within 72 hours of birth between January 2023 and December 2023. Inclusion criteria:
Admitted to the NICU within 72 hours of birth.
Clinically suspected or confirmed EONS based on physician diagnosis and laboratory results.
Data Collection:
Data were extracted from medical records, including:
Demographics: Age, sex, gestational age at birth.
Clinical data: Apgar scores, mode of delivery.
Maternal markers: Premature rupture of membranes, intrapartum fever, maternal infections, and other relevant obstetric factors.
Laboratory results: Blood culture, CRP, Procalcitonin levels.
Cutaneous manifestations: The study also included cutaneous markers of neonatal sepsis such as petechiae, purpura, cyanosis, or mottling of the skin.
Definitions:
EONS was defined as sepsis occurring within 72 hours of birth, confirmed by positive blood culture results and clinical symptoms.
Outcome Measures:
Primary outcome: Incidence of EONS.
Secondary outcomes: Identification of microbial profiles, cutaneous manifestations, and significant risk factors associated with EONS.
Statistical Analysis:
Descriptive statistics were used to summarize demographic and clinical characteristics. Incidence rates were calculated as the number of EONS cases per total NICU admissions. Logistic regression was employed to assess risk factors for EONS, producing odds ratios (ORs) with 95% confidence intervals (CIs). Receiver Operating Characteristic (ROC) curves were used to assess diagnostic accuracy, and areas under the curve (AUC) were reported. ROC plots and CIs were also displayed graphically. Comparison of incidence rates between current and previous years was performed to evaluate trends.
Ethical Considerations:
The study received approval from the Institutional Ethics Committee of Mamata Medical College, Khammam. Patient data were anonymized to ensure confidentiality, in line with the Declaration of Helsinki.
A total of 100 neonates were included in the study, with a median gestational age of 37 weeks (interquartile range: 34-39 weeks) and a range of 32 to 42 weeks. Among the participants, 52 were male (52%) and 48 were female (48%). Additionally, 60 neonates (60%) were from urban areas, while 40 (40%) were from suburban regions (Table 1).
Table 1: Participant Demographics
Category |
Number |
Percentage (%) |
Total Neonates |
100 |
100 |
Male Neonates |
52 |
52 |
Female Neonates |
48 |
48 |
Urban Neonates |
60 |
60 |
Suburban Neonates |
40 |
40 |
Out of the 100 neonates, 18 were diagnosed with early-onset neonatal sepsis (EONS), resulting in an incidence rate of 18%. Among these 18 cases, 16 were confirmed by positive blood cultures, while 2 were diagnosed based on clinical symptoms and laboratory findings without positive culture results (Table 2).
Table 2: Incidence of Early-Onset Neonatal Sepsis
Total Neonates |
Neonates with EONS |
Incidence Rate (%) |
Blood Culture Confirmed Cases |
Diagnosed by Symptoms |
100 |
18 |
18 |
16 |
2 |
The predominant pathogens identified in the neonates diagnosed with EONS were Escherichia coli (44%), followed by Group B Streptococcus (28%) and Staphylococcus aureus (17%). Mixed flora accounted for 11% of the cases (Table 3).
Table 3: Microbial Profile of EONS Cases
Pathogen |
Number of Cases |
Percentage (%) |
Escherichia coli |
7 |
44 |
Group B Streptococcus |
5 |
28 |
Staphylococcus aureus |
3 |
17 |
Mixed Flora |
2 |
11 |
Several cutaneous signs were observed in neonates diagnosed with EONS. These included petechiae (4 cases), cyanosis (6 cases), mottling of the skin (3 cases), and purpura (2 cases). These manifestations were significantly associated with more severe disease presentations and were often accompanied by elevated inflammatory markers such as C-reactive protein (CRP) and procalcitonin (Table 4).
Table 4: Cutaneous Manifestations of EONS
Manifestation |
Number of Cases |
Petechiae |
4 |
Cyanosis |
6 |
Mottling of the Skin |
3 |
Purpura |
2 |
Multivariable logistic regression identified several significant risk factors associated with the development of EONS. Premature rupture of membranes (OR = 4.3, 95% CI: 1.8-10.2, p = 0.001), maternal intrapartum fever (OR = 2.8, 95% CI: 1.1-7.2, p = 0.03), cesarean section delivery (OR = 3.1, 95% CI: 1.4-6.9, p = 0.005), and low Apgar score at 5 minutes (OR = 5.5, 95% CI: 2.3-13.1, p < 0.001) were all found to significantly increase the risk of EONS (Table 5).
Table 5: Risk Factors Analysis (Multivariable Logistic Regression)
Risk Factor |
Odds Ratio (OR) |
95% Confidence Interval (CI) |
p-value |
Premature Rupture of Membranes |
4.3 |
1.8-10.2 |
0.001 |
Maternal Intrapartum Fever |
2.8 |
1.1-7.2 |
0.03 |
Cesarean Section Delivery |
3.1 |
1.4-6.9 |
0.005 |
Low Apgar Score at 5 Minutes |
5.5 |
2.3-13.1 |
<0.001 |
Several maternal factors were noted to contribute to the risk of EONS. Premature rupture of membranes was present in 20% of the cases, maternal intrapartum fever in 12%, and chorioamnionitis in 6%. Additional factors, such as prolonged labor and maternal infections like urinary tract infections (UTIs) and bacterial vaginosis, were also commonly reported but not quantified in this analysis (Table 6).
Table 6: Maternal Markers
Maternal Risk Factor |
Percentage of Cases (%) |
Premature Rupture of Membranes |
20 |
Intrapartum Fever |
12 |
Chorioamnionitis |
6 |
A slight decline in the incidence of EONS was observed, decreasing from 20% in 2022 to 18% in 2023. This trend may indicate improving clinical management and preventive measures in neonatal care.
Figure No:1 Incidence of Early Onset Neonatal Sepsis
Figure No:2 Microbial Profile of Neonatal Sepsis Cases
Figure No:3 Cutaneous Manifestations of EONS
Figure No: 4.ROC Curve for EONS Diagnostic Model
ROC analysis was conducted to assess the diagnostic accuracy of the combined model, including clinical markers, laboratory markers, maternal factors, and cutaneous manifestations. The area under the curve (AUC) for this model was 0.85 (95% CI: 0.78-0.92), suggesting strong diagnostic performance. The corresponding ROC and confidence interval plots provide visual representations of diagnostic accuracy and risk stratification for EONS, emphasizing the role of these factors in early detection.
Our study identified an 18% incidence rate of early-onset neonatal sepsis (EONS) among neonates admitted to the NICU within 72 hours of birth. The predominant pathogens were Escherichia coli, Group B Streptococcus, and Staphylococcus aureus. Significant risk factors included premature rupture of membranes, maternal intrapartum fever, delivery by caesarean section, and a low Apgar score at 5 minutes10,11.
Microbial Profile: The predominance of Escherichia coli and Group B Streptococcus aligns with global trends and emphasizes the need for vigilant prenatal screening and appropriate antibiotic prophylaxis.
Risk Factors: The strong association of EONS with factors such as premature rupture of membranes and low Apgar scores highlights the importance of early intervention and monitoring in at-risk deliveries12. The increased risk associated with caesarean deliveries could be indicative of the surgical environment or pre-existing maternal conditions that necessitate surgical intervention.
Trend Analysis: The slight decline in the incidence of EONS compared to the previous year could suggest improvements in prenatal care, infection control practices, or both. This finding is encouraging but warrants continued efforts to sustain and enhance these outcomes.
Our findings are consistent with other studies emphasizing the need for targeted interventions in the prenatal and perinatal periods to mitigate the risks of EONS. The identification of specific microbial agents and risk factors corroborates the literature, suggesting that our results are applicable in similar urban hospital settings13,14.
Implications for Practice:
Prenatal Care: Enhancing prenatal screening and treatment for infections can reduce the incidence of EONS. Educational programs for expecting mothers about the importance of timely medical consultations and interventions could be beneficial.
Intrapartum Care: Strict monitoring and management of labor, especially in cases with known risk factors like fever or premature rupture of membranes, could reduce EONS incidence.
Postnatal Care: Immediate assessment and intervention for neonates born with low Apgar scores or through cesarean section are crucial for early detection and management of EONS.
Future Research: Further studies are needed to explore the impact of specific interventions in the prenatal and perinatal periods on the incidence of EONS. Additionally, research into the evolving microbial patterns and resistance profiles can help tailor antibiotic strategies more effectively.
Limitations: The retrospective nature of the study and the reliance on hospital records may limit the comprehensiveness and accuracy of the data. Prospective studies could provide more controlled and detailed data to better understand the causal relationships and efficacy of different intervention strategies.
This study highlights the significant burden of early-onset neonatal sepsis (EONS) in a large urban hospital setting, with an incidence of 18%. Key risk factors, including premature rupture of membranes, maternal fever, cesarean section delivery, and low Apgar scores, were strongly associated with EONS. Additionally, cutaneous manifestations such as petechiae, cyanosis, mottling, and purpura were commonly observed and correlated with more severe sepsis cases. The predominant pathogens identified were Escherichia coli, Group B Streptococcus, and Staphylococcus aureus. Understanding these factors is crucial for improving early detection, guiding empirical therapy, and reducing EONS-related morbidity and mortality in neonates.
Acknowledgment
I would like to extend my sincere gratitude and special thanks to Dr. Sindhu for her invaluable support in identifying the risk factors and her significant contribution to the collection of samples for this study. I would also like to express my heartfelt thanks and special appreciation to Ravi Chandra for his dedicated assistance with the statistical analysis, which greatly contributed to the thorough evaluation of the data. Their guidance and expertise have been instrumental in shaping this research.