Early-onset sepsis risk calculator: a review of its effectiveness and comparative study with our evidence-based local guidelines

Abstract

Background: According to most early-onset sepsis (EOS) management guidelines, approximately 10% of the total neonatal population are exposed to antibiotics in the first postnatal days with subsequent increase of neonatal and pediatric comorbidities. A review of literature demonstrates the effectiveness of EOS calculator in reducing antibiotic overtreatment and NICU admission among neonates ≥34 weeks' gestational age (GA); however, some missed cases of culture-positive EOS have also been described.

Methods: Single-center retrospective study from 1st January 2018 to 31st December 2018 conducted in the Division of Neonatology at Santa Chiara Hospital (Pisa, Italy). Neonates ≥34 weeks' GA with birth weight ≤ 1500 g, 34-36 weeks' GA neonates with suspected intraamniotic infection and neonates ≥34 weeks' GA with three clinical signs of EOS or two signs and one risk factor for EOS receive empirical antibiotics. Neonates ≥34 weeks' GA with risk factors for EOS or with one clinical indicator of EOS undergo serial measurements of C-reactive protein and procalcitonin in the first 48-72 h of life; they receive empirical antibiotics in case of abnormalities at blood exams with one or more clinical signs of EOS. Two hundred sixty-five patients at risk for EOS met inclusion criteria; they were divided into 3 study groups: 34-36 weeks' GA newborns (n = 95, group A), ≥ 37 weeks' GA newborns (n = 170, group B), and ≥ 34 weeks' GA newborns (n = 265, group A + B). For each group, we compared the number of patients for which antibiotics would have been needed, based on EOS calculator, and the number of the same patients we treated with antibiotics during the study period. Comparisons between the groups were performed using McNemar's test and statistical significance was set at p < 0.05; post-hoc power analysis was carried out to evaluate the sample sizes.

Results: 32/265 (12.1%) neonates ≥34 weeks' GA received antibiotics within the first 12 h of life. According to EOS calculator 55/265 (20.7%) patients would have received antibiotics with EOS incidence 2/1000 live births (p < 0.0001).

Conclusion: Our evidence-based protocol entails a further decrease of antibiotic overtreatment compared to EOS calculator. No negative consequences for patients were observed.

Keywords: Antibiotics; C-reactive protein; Early-onset sepsis; Early-onset sepsis risk calculator; Procalcitonin.

Fig. 1

Selection process of the study population. Legends: EOS, early-onset sepsis; GA, gestational age

Fig. 2

Comparison between our local guidelines and EOS calculator. Neonates ≥34 weeks’ GA. Legends: EOS, early-onset sepsis; GA, gestational age; GBS, Group B Streptococcus; IAP, intrapartum antibiotic prophylaxis; R1, recommendation No. 1 (No culture, no antibiotics, routine vitals); R2, recommendation No. 2 (No culture, no antibiotics, vitals every 4 h for 24 h); R3, recommendation No. 3 (Blood culture, vitals every 4 h for 24 h); R4, recommendation No. 4 (Strongly consider starting empiric antibiotics, vitals per NICU); R5, recommendation No. 5 (Empiric antibiotics, vitals per NICU)

Fig. 3

Comparison between our local guidelines and EOS calculator. Neonates 34–36 weeks’ GA. Legends: EOS, early-onset sepsis; GA, gestational age; GBS, Group B Streptococcus; IAP, intrapartum antibiotic prophylaxis; R1, recommendation No. 1 (No culture, no antibiotics, routine vitals); R2, recommendation No. 2 (No culture, no antibiotics, vitals every 4 h for 24 h); R3, recommendation No. 3 (Blood culture, vitals every 4 h for 24 h); R4, recommendation No. 4 (Strongly consider starting empiric antibiotics, vitals per NICU); R5, recommendation No. 5 (Empiric antibiotics, vitals per NICU)

Fig. 4

Comparison between our local guidelines and EOS calculator. Neonates ≥37 weeks’ GA. Legends: EOS, early-onset sepsis; GA, gestational age; GBS, Group B Streptococcus; IAP, intrapartum antibiotic prophylaxis; R1, recommendation No. 1 (No culture, no antibiotics, routine vitals); R2, recommendation No. 2 (No culture, no antibiotics, vitals every 4 h for 24 h); R3, recommendation No. 3 (Blood culture, vitals every 4 h for 24 h); R4, recommendation No. 4 (Strongly consider starting empiric antibiotics, vitals per NICU); R5, recommendation No. 5 (Empiric antibiotics, vitals per NICU)