Clinical assessment of neutrophil gelatinase-associated lipocalin as a potential diagnostic marker for neonatal sepsis: a prospective cohort study

Sepsis is a life-threatening condition associated with high morbidity and mortality rates among neonates. Clinical diagnosis is limited due to the neonates' unspecific signs and symptoms as well as the long time required to obtain the blood culture results. Consequently, there is an urgent need for new biomarkers to early diagnose neonatal sepsis. We aimed to evaluate Neutrophil Gelatinase-Associated Lipocalin (NGAL) diagnostic performance to detect neonatal sepsis. We enrolled 30 neonates with sepsis admitted to the neonatal intensive care units and 30 age- and sex-matched healthy neonates recruited from the neonatal outpatient clinic during their routine follow-up visits. We measured NGAL levels by sandwich enzyme-linked immunosorbent assay, the C-reactive protein (CRP) with nephelometry technique using BN II nephelometer, and the complete blood count by Mindray BC-6800 analysers. NGAL, CRP, TLC, haemoglobin, and platelet levels showed significant differences between cases and control (all p < .001). Of the 30 neonates with sepsis, 17 neonates (56.7%) survived. At 0 h, the NGAL level showed no statistically significant difference between the non-survivors and survivors' groups; however, after 96 h, NGAL was significantly higher in the non-survivors group (p < .001). Our diagnostic analysis showed that NGAL levels have strong discrimination power to early differentiate neonates with sepsis; at the 475.00 pg/ml cut-off value, NGAL showed both sensitivity and specificity of 100% with an area under curve of 100%. Conclusion: Our study suggests that NGAL could be a promising biomarker for neonatal sepsis detection. Further studies with larger sample sizes and survival analysis are warranted to confirm this finding and to clarify the efficacy of NGAL in survival prediction. Key findings NGAL level was high in neonates with sepsis NGAL level was high in non-survived neonates NGAL could be a promising diagnostic marker for sepsis

Automated summary

Sepsis is a life-threatening condition in neonates, and its diagnosis is challenging. This study evaluated the diagnostic performance of NGAL as a biomarker for early detection of neonatal sepsis. NGAL levels showed significant differences between sepsis cases and controls, and were significantly higher in non-survivors. NGAL demonstrated strong discriminatory power and could potentially serve as a promising diagnostic marker for neonatal sepsis.