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Can a neonatal sepsis risk calculator safely decrease unnecessary evaluation for neonatal sepsis and the number of newborns exposed to antibiotics?

Although the incidence of Group B strep early-onset sepsis (EOS) decreased from 1.8 to 0.25 cases per 1,000 between 1990 and 2010, the number of uninfected newborns receiving bloodwork and empiric antibiotics has increased to hundreds of thousands annually. The drop in EOS has been attributed to the use of the Center for Disease Control’s Group B Strep Guidelines, which recommended antenatal testing and intrapartum intravenous antibiotic prophylaxis when positive. However, with current CDC guidelines, approximately 200 newborns are treated for EOS for every newborn who has EOS. Since 2011, several cohort studies have demonstrated that the Kaiser Permanente Neonatal Early-Onset Sepsis Calculator for term/late preterm newborns can decrease the number of babies receiving evaluation and/or treatment for EOS without increasing the incidence of adverse outcomes. The sepsis risk calculator cannot be applied before 34 weeks. The sepsis calculator considers 1) incidence of EOS, 2) gestational age, 3) highest maternal temperature, 4) hours of ruptured membranes, 5) maternal GBS status, and 6) presence and type of intrapartum antibiotic prophylaxis. It calculates 1) EOS risk/1,000 births and 2) gives modified risk, clinical recommendation, and vital signs if newborn is well appearing, equivocal, or clinical illness. A meta-analysis of five prospective cohort studies involving 18,352 infants found that theKaiser Neonatal EarlyOnset Sepsis Calculator compared with CDC 2010 GBS guidelines decreased testing and treatment.Only onenewborn in the five studies had clinical deterioration and NICU admission despite receiving a low score on the risk calculator and no recommendation for antibiotic administration; the baby was GBS negative and would not have received empiric antibiotics by the 2010 GBS guidelines either. Use of the calculator led to decreased use of antibiotics (risk ratio [RR], 0.46; 95% CI, 0.41–0.51), blood cultures (RR, 0.46; 95% CI, 0.40–0.52), and neonatal intensive care unit admissions (RR, 0.68; 95% CI, 0.59–0.78). A retrospective cohort study comparing 56,261 newborns born at 35 or more weeks of gestation where the Kaiser Neonatal Early-Onset Sepsis Calculator was used with 95,343 in a baseline control period found a statistically significant drop in the use of blood cultures and empiric antibiotics in first 24 hours with no statistical difference in positive blood cultures, readmission, need for inotropes, mechanical ventilation, meningitis, or death. Blood culture use decreased from 14.5% to 4.9% (95% CI, –13.1% to –2.4%). Empirical antibiotic administration in the first 24 hours decreased from 5.0% to 2.6% (95% CI, –2.4% to –1.3%). A retrospective nested case-control study identified 350 cases of EOS from 608,014 live births at 34 or more weeks gestation and compared them with 1,063 matched controls and used the Kaiser Neonatal Early-Onset Sepsis Calculator to divide them into three groups: treat empirically (4.1% of all live births, 60.8% of all EOS cases, sepsis incidence of 8.4/1,000 live births), observe and evaluate (11.1% of live births, 23.4% of EOS cases, sepsis incidence of 1.2/1,000), and continued observation (84.8% of live births, 15.7% of EOS cases, sepsis incidence of 0.11/ 1,000). It was determined that this approach would drop the percentage of babies given empiric antibiotics from 6–10% to 4%. Extrapolating to the approximately four million births in the United States each year, the use of empiric antibiotics would drop by 80,000-240,000 patients annually. A 2019 NICU retrospective cohort study comparing 263 newborns born the year before the intervention with 276 newborns born the year after the intervention that involved 1) application of the Kaiser Neonatal Early-Onset Sepsis Calculator initially with empiric antibiotics started when indicated by the calculator and 2) stopping empiric antibiotics after 36 hours rather than 48 hours if cultures