Serial physical examination to reduce unnecessary antibiotic exposure in newborn infants: a population-based study

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OBJECTIVES: While antibiotics save lives in infants with sepsis, up to 12.0% of non-infected term and late preterm infants are exposed to antibiotics underscoring diagnostic challenges in early onset sepsis (EOS).This study aimed to assess whether serial physical examination (SPE) in neonatal intensive care units (NICUs) could safely reduce early antibiotic exposure in infants born at ≥34 weeks' gestation at risk for EOS. DESIGN: A population-based, multicentre interventional study from 2018 throughout 2021. SETTING: Six Norwegian tertiary and secondary level NICUs. PATIENTS: In total, 54 713 liveborn infants were eligible for inclusion. INTERVENTIONS: Infants at risk for EOS (mild/transient clinical signs, chorioamnionitis-exposed or group B streptococcus sepsis in a sibling) were clinically monitored with SPE for 24-48 hours. Infants with no/transient clinical signs did not receive antibiotics, whereas treatment was initiated without delay if signs indicated severe EOS, clinical condition deteriorated despite intervention or vital signs failed to improve. MAIN OUTCOME MEASURES: Comparative statistics were used to evaluate changes after implementing SPE, including percentage of infants exposed to antibiotics, incidence of EOS, NICU and safety outcomes (time from birth to antibiotics administration in EOS, infection-related deaths and re-admissions for infection). A statistical process control chart was used to evaluate antibiotic exposure over time. RESULTS: Infants exposed to antibiotics were reduced by 50%, from 1.8% (95% CI 1.6% to 2.0%) to 0.9% (95% CI 0.8% to 1.1%).Incidence of culture-positive EOS, NICU admission rates and safety outcomes remained unchanged. CONCLUSION: SPE reduced antibiotic exposure in infants ≥34 weeks' gestation without compromising safety.