Neonatal Early Onset Sepsis (EOS) Calculator plus Universal Serial Physical Examination (SPE): A Prospective Two-Step Implementation of a Neonatal EOS Prevention Protocol for Reduction of Sepsis Workup and Antibiotic Treatment

Abstract

Current neonatal early-onset sepsis (EOS) guidelines lack consensus. Recent studies suggest three different options for EOS risk assessment among infants born ≥35 wks gestational age (GA), leading to different behaviors in the sepsis workup and antibiotic administration. A broad disparity in clinical practice is found in Neonatal Units, with a large number of non-infected newborns evaluated and treated for EOS. Broad spectrum antibiotics in early life may induce different short- and long-term adverse effects, longer hospitalization, and early mother-child separation. In this single-center prospective study, a total of 3002 neonates born in three periods between 2016 and 2020 were studied, and three different workup algorithms were compared: the first one was based on the categorical risk assessment; the second one was based on a Serial Physical Examination (SPE) strategy for infants with EOS risk factors; the third one associated an informatic tool (Neonatal EOS calculator) with a universal extension of the SPE strategy. The main objective of this study was to reduce the number of neonatal sepsis workups and the rate of antibiotic administration and favor rooming-in and mother–infant bonding without increasing the risk of sepsis and mortality. The combined strategy of universal SPE with the EOS Calculator showed a significant reduction of laboratory tests (from 33% to 6.6%; p < 0.01) and antibiotic treatments (from 8.5% to 1.4%; p < 0.01) in term and near-term newborns. EOS and mortality did not change significantly during the study period.

Early initiation of antibiotic therapy and short-term outcomes in preterm infants: a single-centre retrospective cohort analysis

“…For late preterm and term infants, it has been shown repeatedly that implementation of a sepsis calculator could significantly reduce the proportion of newborns empirically treated with antibiotics. [29][30][31][32][33] For VLBWI, there is yet a lack of corresponding studies. Nonetheless, major efforts should be made to develop algorithms that could better predict the risk of EOS and help reduce antibiotic use also in this population.…”

“…Nevertheless, a growing body of evidence suggests that antibiotics in VLBWI can and should be managed more restrictively. For late preterm and term infants, it has been shown repeatedly that implementation of a sepsis calculator could significantly reduce the proportion of newborns empirically treated with antibiotics 29–33. For VLBWI, there is yet a lack of corresponding studies.…”

Evaluating the Impact of the 2017 Dutch Neonatal Early-Onset Sepsis Guideline

“…To prevent further unnecessary antibiotic treatment, we advocate the need for a new screening strategy, possibly in the form of a value-based (multivariate) approach such as the EOS calculator in combination with a serial physical examination. 12…”

“…However, a systematic review and meta-analysis found that management guided by an early-onset sepsis calculator was associated with a significant reduction in empirical antibiotic therapy compared with conventional management, with a relative risk of 56% in before-after implementation studies. 11 Furthermore, Cavigioli et al 12 demonstrated that the combination of the neonatal EOS calculator and serial physical examinations can reduce the empirical antibiotic rate even more, to 1.4%. This illustrates that a categorical approach may be associated with unnecessary diagnostics and treatment and thus is not the best way to approach neonates and EOS risk.…”

The Management of Neonates ≥34 Weeks’ Gestation at Risk of Early Onset Sepsis: A Pilot Study

“…It includes the combination of EOS calculator and SPE for all newborns with the possibility of evaluating the administration of antibiotic therapy in infants showing only mild respiratory symptoms with other systemic signs. Combined strategy seems to significantly reduce laboratory testing and antibiotic prescriptions [ 36 ].…”