A comparison between early onset sepsis (EOS) risk calculator and modified new protocol in a newborn ≥ 35 weeks: a simulation study

BACKGROUND: Early onset sepsis (EOS) is a potentially fatal condition in neonates and its correct management is still a challenge for neonatologists. Early antibiotic administration in the neonatal period may carry risks and reducing unnecessary antibiotic therapy remains a key objective. It is well known that EOS risk calculator has reduced investigations and antibiotics for suspected EOS, but many limitations have been identified (e.g. strong value to respiratory symptoms, lack of standardized neonatal monitoring). To develop a new protocol, called Neosafe, for the management of newborn ≥ 35 weeks at risk of EOS based on the EOS risk calculator and serial physical examination with the aim of reducing blood investigations and unnecessary antibiotic therapy. METHODS: In this single-center observational retrospective study 2000 Neonates ≥ 35 weeks were enrolled. A new protocol called Neosafe has been developed, which deviates from the original for two major changes: (1) different serial physical examination (SPE) recommendation for each risk situations (2) clinical scenario revisited with multiple signs. Comparison between Neosafe protocol and EOS risk calculator simulated data were performed using McNemar's test (statistical significance p < 0,05) and the Cohen's kappa coefficient was used to assess the degree of agreement among them. RESULTS: 48/2000 infants (2,4%) would have performed blood investigations versus 82/2000 (4,1%) whether Neosafe protocol would have been applied (p < 0,0001). 43/2000 infants (2,2%) with Neosafe protocol would have received antibiotics versus 80/2000 (4,0%) with EOS risk calculator (p < 0,0001). All infants who would not receive antibiotics for Neosafe protocol were infants with equivocal signs and isolated mild to moderate respiratory distress, but predisposed to advanced medical monitoring. Proven sepsis during the study period were 4, 2 of them were lost by both (no symptoms at birth, blood tests performed for non-infectious reasons). 1829 infants (91,5%) would receive routinal nursing SPE monitoring, 128 advanced medical SPE monitoring and 43 advanced medical SPE+vital for neonatal intensive care unit (NICU). CONCLUSIONS: In our study Neosafe protocol could have reduced blood investigations and antibiotic therapy. Neosafe protocol could be a promising tool that integrates the use of digital technologies and direct attention to the patients. More trials are needed for further improvements.