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

Abstract

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

Keywords:

• Neutrophil gelatinase-associated lipocalin
• NGAL
• diagnostic
• neonates
• sepsis

Author contributions

Conception and design: Dina Abdel Razek Midan, Fady Mohammed El-Gendy, Mayada Hazem Kotb. Analysis and interpretation of the data: Dina Abdel Razek Midan, Fady Mohammed El-Gendy, Dalia Hosny Abo ELAlla. Drafting of the paper: Dina Abdel Razek Midan, Fady Mohamed El-Gendy, Mayada Hazem Kotb, Dalia Hosny Abo ELAlla. Mansucript revision for intellectual content: Dina Abdel Razek Midan, Mayada Hazem Kotb. Final approval of the version: Dina Abdel Razek Midan, Fady Mohammed El-Gendy, Mayada Hazem Kotb, Dalia Hosny Abo ELAlla. All authors agree to be accountable for all aspects of the work.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Data are available upon reasonable request by contacting the corresponding author.