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Serial physical examination to reduce unnecessary antibiotic exposure in newborn infants: a population-based study
Anlaug Vatne1, Beate Horsberg Horsberg Eriksen2,3, Fabian Bergqvist4
1Department of Pediatrics, Stavanger University Hospital, Stavanger, Norway anlaug.vatne@sus.no.
Insights
Serial physical examination (SPE) safely reduced early antibiotic exposure by 50% in infants at risk for early onset sepsis (EOS) without impacting safety outcomes. This approach aids in judicious antibiotic use in neonatal intensive care units (NICUs).
Area of Science:
- Neonatal Medicine
- Pediatric Infectious Diseases
- Clinical Pharmacology
Background:
- Antibiotic overuse in neonatal intensive care units (NICUs) for infants at risk of early onset sepsis (EOS) poses challenges.
- Diagnostic uncertainty leads to unnecessary antibiotic exposure in up to 12.0% of non-infected infants.
- Developing safe, effective strategies to reduce early antibiotic exposure is critical.
Purpose of the Study:
- To evaluate the safety and efficacy of serial physical examination (SPE) in reducing early antibiotic exposure in infants at risk for EOS.
- To assess the impact of SPE on key safety outcomes, including incidence of EOS and infection-related adverse events.
Main Methods:
- A population-based, multicentre interventional study conducted in six Norwegian NICUs from 2018 to 2021.
- Inclusion of 54,713 liveborn infants born at or after 34 weeks' gestation at risk for EOS.
- Implementation of a 24-48 hour SPE protocol for clinical monitoring, guiding antibiotic initiation based on clinical signs and stability.
Main Results:
- Antibiotic exposure in infants at risk for EOS was reduced by 50%, from 1.8% to 0.9%.
- The incidence of culture-positive EOS, NICU admission rates, and overall safety outcomes remained unchanged.
- No significant differences were observed in time to antibiotic administration for confirmed EOS or infection-related re-admissions.
Conclusions:
- Serial physical examination (SPE) is a safe and effective strategy for reducing unnecessary antibiotic exposure in infants at risk for early onset sepsis (EOS).
- This approach allows for judicious antibiotic use in neonatal intensive care units (NICUs) without compromising patient safety.
- SPE supports evidence-based clinical decision-making in neonatal sepsis management.
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.
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