Technical assessment of the neonatal early-onset sepsis risk calculator

Benitz, William Ε.; Achten, Niek B.

doi:10.1016/s1473-3099(20)30490-4

Cited by 31 publications

(26 citation statements)

References 34 publications

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“…For consistency, we used a homogenous incidence of 0.6 per 1000 live births, closest to that in the development sample. 19 The incidence can be adjusted to tailor the tool to a specific population, but this requires prior calibration and/or validation. 19 This is analogous to altering the threshold for treatment in the opposite direction (a higher incidence mimics a lower treatment threshold), which can be a clinical decision.…”

Section: Application Of the Eos Calculator And Data Analysismentioning

confidence: 99%

“…19 The incidence can be adjusted to tailor the tool to a specific population, but this requires prior calibration and/or validation. 19 This is analogous to altering the threshold for treatment in the opposite direction (a higher incidence mimics a lower treatment threshold), which can be a clinical decision. 20 Additional analysis was performed to assess effects of different treatment thresholds or population incidences (as offered by the online EOS Calculator) on the proportion of EOS cases assigned treatment.…”

Section: Application Of the Eos Calculator And Data Analysismentioning

confidence: 99%

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Stratification of Culture-Proven Early-Onset Sepsis Cases by the Neonatal Early-Onset Sepsis Calculator: An Individual Patient Data Meta-Analysis

Achten

Plötz

Klingenberg

et al. 2021

The Journal of Pediatrics

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Objectives To provide a comprehensive assessment of case stratification by the Neonatal Early-Onset Sepsis (EOS) Calculator, a novel tool for reducing unnecessary antibiotic treatment.Study design A systematic review with individual patient data meta-analysis was conducted, extending PROS-PERO record CRD42018116188. Cochrane, PubMed/MEDLINE, EMBASE, Web of Science, Google Scholar, and major conference proceedings were searched from 2011 through May 1, 2020. Original data studies including culture-proven EOS case(s) with EOS Calculator application, independent from EOS Calculator development, and including representative birth cohorts were included. Relevant (individual patient) data were extracted from full-text and data queries. The main outcomes were the proportions of EOS cases assigned to risk categories by the EOS Calculator at initial assessment and within 12 hours. Evidence quality was assessed using Newcastle-Ottawa scale, Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies, and GRADE tools.Results Among 543 unique search results, 18 were included, totaling more than 459 000 newborns. Among 234 EOS cases, EOS Calculator application resulted in initial assignments to (strong consideration of) empiric antibiotic administration for 95 (40.6%; 95% CI, 34.2%-47.2%), more frequent vital signs for 36 (15.4%; 95% CI, 11.0%-20.7%), and routine care for 103 (44.0%; 95% CI, 37.6%-50.6%). By 12 hours of age, these proportions changed to 143 (61.1%; 95% CI, 54.5%-67.4%), 26 (11.1%; 95% CI, 7.4%-15.9%), and 65 (27.8%; 95% CI, 22.1%-34.0%) of 234 EOS cases, respectively.Conclusions EOS Calculator application assigns frequent vital signs or routine care to a substantial proportion of EOS cases. Clinical vigilance remains essential for all newborns.

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Section: Application Of the Eos Calculator And Data Analysismentioning

confidence: 99%

Section: Application Of the Eos Calculator And Data Analysismentioning

confidence: 99%

Stratification of Culture-Proven Early-Onset Sepsis Cases by the Neonatal Early-Onset Sepsis Calculator: An Individual Patient Data Meta-Analysis

Achten

Plötz

Klingenberg

et al. 2021

The Journal of Pediatrics

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“…The neonatal early-onset sepsis risk calculator, developed by Kaiser Permanente (California, USA), is increasingly used to predict the risk of EOS in late preterm and term neonates [ 18 ] and to decide whether to start antibiotics or not. Its introduction in the clinical practice has reduced antibiotics prescription [ 19 ], even if data on its safety are poor [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Time to Positivity of Blood Cultures Could Inform Decisions on Antibiotics Administration in Neonatal Early-Onset Sepsis

et al. 2021

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(1) Background: Empirical antibiotics for suspected neonatal early-onset sepsis are often prolonged administered, even in the absence of clinical signs of infection, while awaiting the blood cultures results. The C-reactive protein is widely used to guide antibiotic therapy, although its increase in the first hours of life is not always evidence of infection. The aim of this study was to evaluate the time to positivity (TTP) of blood cultures (BC) that develop pathogens in our population of neonates and determine whether TTP could safely inform the decisions on empirical antibiotic discontinuation in neonatal early-onset sepsis and reduce the use of unnecessary antibiotics. (2) Methods: We retrospectively collected data of all newborns ≥ 34 weeks admitted to the Neonatal Intermediate-Care Unit at Policlinico “A. Gemelli” University Hospital (Rome, Italy) from 2014 to 2018, with suspected early-onset sepsis (EOS). The TTP was the time in hours from the first BC inoculation to the bacterial growth. We defined as positive BC only those with a pathogenic organism. (3) Results: In total, 103 out of 20,528 infants born in the five-year study period were admitted to our Neonatal Intermediate-Care Unit because of a suspected EOS and enrolled into the study. The mean TTP of pathogenic organisms was 17.7 ± 12.5 h versus 80.5 ± 55.8 h of contaminants (p = 0.003). We found ten positive BCs. The TTP of BC was lower than 12, 36, and 48 h in 80%, 90%, and 100% of cases, respectively. CRP levels on admission were similar in infants with a positive and negative BC (p = 0.067). The discontinuation of therapy in asymptomatic infants 48 h after initiation would have resulted in a saving of 217 days of antibiotics (31.1% of total days administered). (4) Conclusion: From our data, the TTP of blood cultures that develop pathogens is less than 48 h in 100% of cases. Therefore, in late preterm and full-term infants with suspected EOS, stopping empiric antibiotics 48 h after initiation may be a safe practice to reduce unnecessary antibiotic use, when blood cultures are negative and infants asymptomatic.

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“…A posterior risk of EOS < 1, 1-3 and > 3/1000 live births indicated different recommendations (observation, evaluation or antibiotic treatment) [11]. However, in the determination of the final risk, the developers of the model attributed an a priori greater relevance to symptoms, although in absence of strong evidences [12]. Symptoms defined as "equivocal" or "clinical illness" are common in the first hours of life, due to transition to extrauterine life.…”

Section: The Neonatal Sepsis Calculator (Nsc)mentioning

confidence: 99%

“…Developers of NSC introduced safeguards to not discontinue ("strongly consider") antibiotics in infants with clinical symptoms, even if the posterior probability was below the threshold for treatment (< 3 cases/1000 live births) [11]. This recommendation would increase antibiotic exposure in uninfected infants [12].…”

Section: The Neonatal Sepsis Calculator (Nsc)mentioning

confidence: 99%

Brief comments on three existing approaches for managing neonates at risk of early-onset sepsis

et al. 2021

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Background Growing concerns regarding the adverse effects of antibiotics during the first days of life and the marked reduction in the incidence of early-onset sepsis (EOS) are changing the clinical practice for managing neonates at risk of EOS. Strategies avoiding unnecessary antibiotics while promoting mother-infant bonding and breastfeeding deserve to be considered. Main body We compare strategies for managing newborns at risk of EOS recommended by the American Academy of Pediatrics, which are among the most followed recommendations worldwide. Currently three different approaches are suggested in asymptomatic full-term or late preterm neonates: i) the conventional management, based on standard perinatal risk factors for EOS alone, ii) the neonatal sepsis calculator, a multivariate risk assessment based on individualized, quantitative risk estimates (relying on maternal risk factors for EOS) combined with physical examination findings at birth and in the following hours and iii) an approach entirely based on newborn clinical condition (serial clinical observation) during the first 48 h of life. We discuss advantages and limitations of these approaches, by analyzing studies supporting each strategy. Approximately 40% of infants who develop EOS cannot be identified on the basis of maternal RFs or laboratory tests, therefore close monitoring of the asymptomatic but at-risk infant remains crucial. A key question is to know what proportion of babies with mild, unspecific symptoms at birth can be managed safely without giving antibiotics. Conclusions Both neonatal sepsis calculator and serial clinical observation may miss cases of EOS, and clinical vigilance for all neonates is essential There is a need to assess which symptoms at birth are more predictive of EOS, and therefore require immediate interventions, or symptoms that can be carefully reevaluated without necessarily treat immediately the neonate with antibiotics. Studies comparing strategies for managing neonates are recommended.

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Technical assessment of the neonatal early-onset sepsis risk calculator

Cited by 31 publications

References 34 publications

Stratification of Culture-Proven Early-Onset Sepsis Cases by the Neonatal Early-Onset Sepsis Calculator: An Individual Patient Data Meta-Analysis

Stratification of Culture-Proven Early-Onset Sepsis Cases by the Neonatal Early-Onset Sepsis Calculator: An Individual Patient Data Meta-Analysis

Time to Positivity of Blood Cultures Could Inform Decisions on Antibiotics Administration in Neonatal Early-Onset Sepsis

Brief comments on three existing approaches for managing neonates at risk of early-onset sepsis

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