A Quantitative, Risk-Based Approach to the Management of Neonatal Early-Onset Sepsis

Abstract

IMPORTANCE Current algorithms for management of neonatal early-onset sepsis (EOS) result in medical intervention for large numbers of uninfected infants. We developed multivariable prediction models for estimating the risk of EOS among late preterm and term infants based on objective data available at birth and the newborn's clinical status.OBJECTIVES To examine the effect of neonatal EOS risk prediction models on sepsis evaluations and antibiotic use and assess their safety in a large integrated health care system. DESIGN, SETTING, AND PARTICIPANTS The study cohort includes 204 485 infants born at 35 weeks' gestation or later at a Kaiser Permanente Northern California hospital from January 1, 2010, through December 31, 2015. The study compared 3 periods when EOS management was based on (1) national recommended guidelines (baseline period [January 1, 2010, through November 31, 2012]), (2) multivariable estimates of sepsis risk at birth (learning period [December 1, 2012, through June 30, 2014]), and (3) the multivariable risk estimate combined with the infant's clinical condition in the first 24 hours after birth (EOS calculator period [July 1, 2014, through December 31, 2015]). MAIN OUTCOMES AND MEASURES The primary outcome was antibiotic administration in the first 24 hours. Secondary outcomes included blood culture use, antibiotic administration between 24 and 72 hours, clinical outcomes, and readmissions for EOS. RESULTS The study cohort included 204 485 infants born at 35 weeks' gestation or later: 95 343 in the baseline period (mean [SD] age, 39.4 [1.3] weeks; 46 651 male [51.0%]; 37 007 white, non-Hispanic [38.8%]), 52 881 in the learning period (mean [SD] age, 39.3 [1.3] weeks; 27 067 male [51.2%]; 20 175 white, non-Hispanic [38.2%]), and 56 261 in the EOS calculator period (mean [SD] age, 39.4 [1.3] weeks; 28 575 male [50.8%]; 20 484 white, non-Hispanic [36.4%]). In a comparison of the baseline period with the EOS calculator period, blood culture use decreased from 14.5% to 4.9% (adjusted difference, −7.7%; 95% CI, −13.1% to −2.4%). Empirical antibiotic administration in the first 24 hours decreased from 5.0% to 2.6% (adjusted difference, −1.8; 95% CI, −2.4% to −1.3%). No increase in antibiotic use occurred between 24 and 72 hours after birth; use decreased from 0.5% to 0.4% (adjusted difference, 0.0%; 95% CI, −0.1% to 0.2%). The incidence of culture-confirmed EOS was similar during the 3 periods (0.03% in the baseline period, 0.03% in the learning period, and 0.02% in the EOS calculator period). Readmissions for EOS (within 7 days of birth) were rare in all periods (5.2 per 100 000 births in the baseline period, 1.9 per 100 000 births in the learning period, and 5.3 per 100 000 births in the EOS calculator period) and did not differ statistically (P = .70). Incidence of adverse clinical outcomes, including need for inotropes, mechanical ventilation, meningitis, and death, was unchanged after introduction of the EOS calculator.CONCLUSIONS AND RELEVANCE Clinical care algorithms based on individual infant ...

Implementation of the Neonatal Sepsis Calculator in an Australian Tertiary Perinatal Centre

“…We describe a significant reduction in infants undergoing evaluation and treatment for EOS, without adverse effects. Our experience is consistent with a recent study by Kuzniewicz et al [1], and supplies important evidence of the EOS calculator as a simple and safe clinical decision support tool that can reduce the number of uninfected infants assessed and treated for suspected EOS.…”

“…Despite the advances in neonatal medicine, EOS remains a potentially fatal condition that affects approximately 0.3–0.8/1,000 infants born at ≥35 weeks’ gestation in high-resource settings [1, 2]. Current neonatal sepsis management algorithms provide neither a satisfactory framework for consistent and objective risk assessment nor an estimate of patient-specific risks.…”

“…Kuzniewicz et al [1] recently reported that implementation of this algorithm in a large US cohort was safe and resulted in a substantial reduction in the proportion of infants requiring evaluation and/or treatment for suspected EOS. Here, we describe our experience of the implementation of the Neonatal Sepsis Calculator introduction in a large tertiary perinatal centre in Western Australia.…”

Antibiotic utilisation in very low birth weight infants without sepsis or necrotising enterocolitis is associated with multiple adverse outcomes

“…Defining appropriate indications to initiate or discontinue antibiotics is challenging given current limitations of routinely available diagnostic tools, including the lack of highly predictive biomarkers of infection or rapid and reliable bacterial diagnostic tests. A recently published prediction model to estimate the probability of early-onset sepsis has shown promise in limiting antibiotic exposure in more mature preterm and term infants 6. Similar tools could be useful in reducing early antibiotic exposure in the higher-risk very low birthweight population by identifying those infants at low risk for infection.…”

Neonates at Risk of Early-Onset Sepsis: Which Is the Best Approach?

“…The sepsis calculator reduces unnecessary antibiotics; however, a subgroup of infants with high-risk factors is still evaluated or treated with antibiotics, although asymptomatic [3]. …”