[Safety and effectiveness of the early-onset sepsis calculator to reduce antibiotic exposure in at-risk newborns: a cluster-randomised controlled trial].

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