Nederlands tijdschrift voor geneeskunde · 2026
[Safety and effectiveness of the early-onset sepsis calculator to reduce antibiotic exposure in at-risk newborns: a cluster-randomised controlled trial].
СтатьяРандомизированное исследованиеАннотация на английскомМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Janssen Sanne W C M, Plötz Frans B, Achten Niek B
Аннотация
OBJECTIVE: Assessing the safety and effectiveness of the early-onset sepsis (EOS) calculator compared with the categorical guideline in reducing empiric antibiotic treatment in newborns with suspected EOS.
DESIGN: Open-label, cluster-randomised controlled trial in 10 Dutch hospitals, randomised 1:1 to the EOS calculator or the categorical guideline.
METHOD: 1830 newborns (gestational age ≥34 weeks, ≥1 EOS risk factor) were included. Non-inferiority was assessed using four predefined harm criteria (respiratory support, circulatory support, culture-proven EOS, referral to tertiary hospital). Superiority was assessed as reduction of empiric antibiotics <24 hours postpartum.
RESULTS: At least one harm criterion was present in 7.0% (64/915) of the EOS calculator arm, compared to 14.6% (134/915) in the categorical guideline arm (relative risk 0.48; 95% CI 0.36-0.63). Antibiotics were started in 7.2% (66/915) versus 26.6% (243/915), respectively (absolute risk reduction: 19.0%, 95% CI 11.3-26.7).
CONCLUSION: EOS calculator implementation safely reduces empiric antibiotic use in newborns.
DESIGN: Open-label, cluster-randomised controlled trial in 10 Dutch hospitals, randomised 1:1 to the EOS calculator or the categorical guideline.
METHOD: 1830 newborns (gestational age ≥34 weeks, ≥1 EOS risk factor) were included. Non-inferiority was assessed using four predefined harm criteria (respiratory support, circulatory support, culture-proven EOS, referral to tertiary hospital). Superiority was assessed as reduction of empiric antibiotics <24 hours postpartum.
RESULTS: At least one harm criterion was present in 7.0% (64/915) of the EOS calculator arm, compared to 14.6% (134/915) in the categorical guideline arm (relative risk 0.48; 95% CI 0.36-0.63). Antibiotics were started in 7.2% (66/915) versus 26.6% (243/915), respectively (absolute risk reduction: 19.0%, 95% CI 11.3-26.7).
CONCLUSION: EOS calculator implementation safely reduces empiric antibiotic use in newborns.