Diagnostic Accuracy of Clinical Tool 'STOPS' and Serum Procalcitonin for Optimizing Antibiotic Therapy in Neonates Born at ≥ 28 Weeks of Gestation with Neonatal Sepsis

BACKGROUND: Antibiotic therapy is initiated in neonates on suspicion of sepsis. Optimizing therapy is a felt need of clinicians as prolonged injudicious 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. Consecutively admitted neonates with suspected EONS or LONS were enrolled. The 'STOPS' tool comprising sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar was applied at 6 and 12 hours 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 disturbance 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 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.