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

ABSTRACT:

Background

Newborns are at risk for early-onset sepsis (EOS), occurring 0.2-2.0 per 1000 live births, and for antibiotic overtreatment: approximately 5-15% receive antibiotics for suspected EOS under conventional guidelines with categorical risk factor assessment. Use of the multivariate neonatal EOS calculator prediction tool can reduce overtreatment, but no trials have been conducted to compare its safety to these categorical guidelines.

Methods

Between April 12th, 2022, and March 19th, 2024, we conducted an open-label, two-armed, cluster-randomised controlled trial among newborns born at ≥34 weeks' gestational age with ≥1 EOS risk factor, comparing 10 hospitals randomised 1:1 to EOS calculator use versus categorical guideline use (ClinicalTrials.gov number: NCT05274776).

SUBMITTER: van der Weijden BM 

PROVIDER: S-EPMC12359153 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature