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Early-onset sepsis risk calculator: a review of its effectiveness and comparative study with our evidence-based local
Gianluigi Laccetta1, Massimiliano Ciantelli2,3, Cristina Tuoni2
1Division of Neonatology and Neonatal Intensive Care Unit, Department of Maternal and Child Health, Santa Chiara Hospital, University of Pisa, Pisa, Italy. gianluigilaccetta@rocketmail.com.
Insights
This study found that an evidence-based protocol reduced antibiotic overtreatment in neonates compared to the Early-Onset Sepsis (EOS) calculator. The protocol showed no negative patient outcomes, improving early-onset sepsis management.
Area of Science:
- Neonatal Medicine
- Pediatric Infectious Diseases
- Clinical Evidence-Based Practice
Background:
- Early-onset sepsis (EOS) affects approximately 10% of neonates, often leading to antibiotic exposure and increased comorbidities.
- The Early-Onset Sepsis (EOS) calculator can reduce antibiotic overtreatment in neonates ≥34 weeks' gestational age (GA), but may miss some culture-positive cases.
Purpose of the Study:
- To evaluate an evidence-based protocol for managing suspected early-onset sepsis (EOS) in neonates ≥34 weeks' gestational age (GA).
- To compare the protocol's antibiotic prescribing rates against the established EOS calculator.
- To assess the safety and effectiveness of the protocol in reducing antibiotic overtreatment.
Main Methods:
- A single-center retrospective study analyzed 265 neonates ≥34 weeks' GA over one year.
- Antibiotic administration criteria included gestational age, birth weight, suspected intraamniotic infection, clinical signs, risk factors, and C-reactive protein/procalcitonin levels.
- The study compared actual antibiotic use under the protocol with the number of neonates who would have received antibiotics according to the EOS calculator.
Main Results:
- Only 12.1% of neonates received antibiotics within the first 12 hours under the evidence-based protocol.
- The EOS calculator would have indicated antibiotic use for 20.7% of neonates, a statistically significant difference (p < 0.0001).
- The incidence of EOS was 2 per 1000 live births.
Conclusions:
- The evidence-based protocol further reduces antibiotic overtreatment in neonates compared to the EOS calculator.
- No adverse patient outcomes were observed, indicating the protocol's safety.
- This protocol offers a safer and more effective approach to managing suspected early-onset sepsis in neonates.
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.
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