Neonatal sepsis is a systemic infection in newborns with a high risk of severe complications, including septic shock and multiple organ failure. Early diagnosis is challenging due to the nonspecific clinical manifestations in the early stages of the disease. IL-6 is synthesized by macrophages, monocytes, and endothelial cells in response to infection and plays a key role in the proinflammatory cascade. Studies show that IL-6 levels increase in the first hours after the onset of infection, making it a promising marker for the early detection of sepsis in newborns.
Objective of the study
The objective of the study was to determine the role of interleukin-6 as an early biomarker in the diagnosis of neonatal sepsis and to evaluate its sensitivity and specificity in comparison with classical laboratory markers of inflammation, such as C-reactive protein and leukocytosis.
Materials and Methods:
The study was conducted in a neonatal unit. Sixty-five newborns with suspected sepsis (aged up to 28 days) and a control group of 20 healthy infants were included. Patients with suspected sepsis were divided into groups based on infection confirmation by blood culture. All patients underwent a clinical examination and venous blood sampling for IL-6 measurement by ELISA, as well as determination of C-reactive protein and leukocytosis. Statistical analysis included calculation of sensitivity, specificity, and correlation analysis between IL-6 levels and the clinical severity of sepsis.
The average IL-6 level in patients with confirmed sepsis was 140 ± 28 pg /ml, in patients with suspected sepsis it was 72 ± 18 pg /ml, and in the control group it was 15 ± 6 pg /ml. The sensitivity of IL-6 for early diagnosis was 92%, and the specificity was 88%, which is significantly higher compared to CRP and leukocytosis in the early stages of the disease. Correlation analysis showed a strong association between IL-6 levels and the severity of clinical manifestations (r = 0.76; p < 0.001). IL-6 levels increased 6–12 hours before clinical manifestations and an increase in CRP, confirming its value as an early biomarker .
The results confirm that IL-6 is a reliable early biomarker for the diagnosis of neonatal sepsis. Its use enables the detection of infection before the onset of clinical symptoms, which is critical for the timely initiation of antibiotic therapy and the prevention of complications. Combining IL-6 with other inflammatory markers and clinical data improves diagnostic accuracy and predicts disease severity. A limitation of the study is the relatively small sample size and single-center design, requiring confirmation of the results in multicenter studies.
Interleukin-6 plays a key role as an early biomarker in the diagnosis of neonatal sepsis. Its measurement enables the detection of sepsis before the onset of clinical manifestations, increasing diagnostic accuracy and improving the prognosis in newborns. Including IL-6 in standard diagnostic protocols is recommended for timely initiation of therapy and optimizing outcomes.
1. Ng P.C., Lam H.S. Diagnostic markers for neonatal sepsis. Curr Opin Pediatr. 2006;18:125–131.
2. Vazzana N., et al. Interleukin-6 as a marker for sepsis in neonates. Clin Chim Acta. 2010;411:1060–1065.
3. Pierrakos C., Vincent J.L. Sepsis biomarkers: a review. Crit Care. 2010;14:R15.
4. Brocklehurst P., et al. Interleukin-6 in early diagnosis of neonatal sepsis. Arch Dis Child Fetal Neonatal Ed . 2001; 84:F 159–F163.
5. med1.uz — materials on neonatal sepsis and biomarkers . Available at: https://med1.uz
6. Chiesa C., et al. C-reactive protein, interleukin-6, and interleukin-8 in neonatal sepsis. Clin Chem . 1998;44: 1026–1031.
7. Hofer N., et al. Interleukin-6 as an early biomarker of neonatal sepsis. J Perinat Med. 2012;40:587–592.
8. Beltempo M., et al. The predictive value of IL-6 for neonatal sepsis severity. Pediatr Infect Dis J. 2014;33:279–283.
9. Ng P.C., Li K., Chui K.M. Early diagnosis of neonatal sepsis using IL-6. Pediatr Res. 1997;42:239–244.
10. Becker K.L., et al. IL-6 and acute-phase proteins in infection. Clin Chem. 1990;36:313–318.