Diagnostic accuracy of clinical tool ‘STOPS’ and Serum Procalcitonin for optimizing antibiotic therapy in Neonatal Sepsis

Background:  Antibiotic therapy is initiated in neonates on suspicion of sepsis. Optimizing therapy is a felt need of clinicians as injudicious prolonged use increases mortality and morbidity risk. Objective: To evaluate the diagnostic accuracy of clinical tool ‘STOPS’ and serum procalcitonin (PCT) for identifying neonates with early onset neonatal sepsis (EONS) or late onset neonatal sepsis (LONS) and early discontinuation in those with no sepsis. Methods: The study had a prospective analytical design conducted at a tertiary care hospital. All neonates with suspected EONS or LONS were enrolled. The ‘STOPS’ tool comprising of sensorium, temperature, oxygenation, perfusion, skin color and blood sugar was applied at 6 and 12 hr of enrollment. Serum PCT was sent at 12 hr. The sensitivity, specificity, positive and negative predictive value (PPV and NPV), positive and negative likelihood ratio (PLR and NLR) were estimated. Results:  The study enrolled 380 neonates of which 330 were given antibiotics for EONS and 50 for LONS. Temperature recording in the EONS group at 12 hr showed a PPV of 100% and a PLR of 9.1 (7.7 – 18). Perfusion assessment at 12 hr had a PPV of 77% and PLR of 8.25 (2.3 – 29). Skin color assessment at 12 hr it had a PPV of 100% and PLR of 13.5 (9.7 – 27). The diagnostic accuracy of PCT in the EONS group was unremarkable. In the LONS group, skin color at 12 hr had a PPV of 100% and PLR of 11.2 (8.6 – 19.5). The diagnostic accuracy of PCT in the LONS group showed a PPV of 82% and PLR of 7 (1.7 – 29). Conclusion: Identifying abnormal STOPS parameters was superior to PCT alone in EONS and as good as PCT in LONS. The ‘STOPS’ tool allows early identification of neonates with no sepsis thereby optimizing antibiotic use.