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

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 PROSPERO 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.

A Quality Improvement Project to Reduce Antibiotic Utilization and Ancillary Laboratory Tests in the Appraisal of Early-Onset Sepsis in the NICU.

BACKGROUND: Diagnosis and treatment of early-onset sepsis (EOS) of the newborn remains a controversial issue among providers due to the non-infectious symptomology which exists in the newborn period. METHODS: Pre/post interventional quality improvement project in a level III NICU to reduce antibiotic utilization and ancillary laboratory tests with the introduction of an evidence-based guideline for the evaluation of EOS in the NICU. RESULTS: Primary outcome measures include mean number of empiric antibiotic treatment days and utilization rate (AUR), number of laboratory tests ordered, and incidence of unwarranted antibiotic therapy beyond the 48-h rule out period. Mean empiric antibiotic treatment days decreased from 2.94 to 1.58 days and overall antibiotic use decreased from 73.7% to 57.1%. Likewise, the mean AUR decreased from 212.5 to 147.6 days of therapy per 1000 patient days. There was an 86% decline in the number of ancillary tests and unwarranted antibiotic use beyond 48- h was reduced by 74%. DISCUSSION: Guidelines for EOS of the newborn should include a thorough baseline evaluation of the drivers of antibiotic use to create an evidence-based foundation. Reducing unnecessary antibiotic use and EOS evaluations in a safe and effective manner have the potential to lower consumer and healthcare expenditures while improving the long-term health of the newborn in the NICU. CONCLUSIONS: These findings emphasize the importance of implementing an evidence-based protocol for antibiotic stewardship in the NICU. With further research there is the potential to improve the healthcare of newborns while reducing expenditures in a safe, effective evaluation of EOS in the newborn population.

Multivariate risk and clinical signs evaluations for early-onset sepsis on late preterm and term newborns and their economic impact.

There is an increasing evidence that strict evaluation of clinical signs is effective in detecting newborns at risk of early-onset sepsis (EOS) that require antibiotic therapy. In a retrospective case control design, we compared EOS antibiotic indication by clinical signs surveillance with multivariate risk analysis (EOSCalc), and estimate their costs. Newborns ≥ 34 weeks who received EOS antibiotics from June 2014 to December 2016 were studied. Were considered symptomatic those with three clinical signs within first 24 h or two signs and one risk factor present. Cost estimative was done using bottom-up hospital's perspective. Eight thousand three hundred twenty-one were born, 384 were included. Two hundred nineteen (57%) would receive antibiotics by EOSCalc and 64 (16.7%) by clinical signs (p < 0.001). All patients with blood cultures were detected and false-negatives were absent. Total cost was US$ 574,121, estimate US$ 415,576 by EOSCalc, and US$ 314,353 by clinical signs (p < 0.001).Conclusions: The use of EOSCalc and clinical signs surveillance seem to be safe and accurate methods in EOS management. Additionally, the two approaches have shown an economic advantage when compared with the hospital's current practice. What is Known: • EOSCalc is a useful method for screening of EOS in late preterm and term infants. • Presence of clinical signs and/or maternal risk factors are present newborns with EOS. What is New: • Rigorous observation of clinical signs is a more accurate method than EOSCalc to screen for EOS in late preterm and term newborns. • Rigorous observation of clinical signs is more economic than EOSCalc in managing EOS in late preterm and term neonates.

Efficacy and safety of applying a neonatal early-onset sepsis risk calculator in China.

AIM: To evaluate and compare the performance of the early-onset sepsis (EOS) risk calculator with procalcitonin (PCT), complete blood count (CBC) and C-reactive protein (CRP) for predicting neonatal EOS. METHODS: This was a retrospective case-control study of neonates who were ≥34 weeks of gestation and ≤12 h of age at admission to our hospital between January 2017 and December 2018. Neonates with strictly defined EOS and those without evidence of infection were included in this study. We reviewed and collected the laboratory data and medical charts of the included neonates. The EOS risk scores for all neonates were calculated using the EOS risk calculator, and the results were analysed and compared with blood biomarkers. RESULTS: A total of 501 neonates, including 353 infected and 148 uninfected infants, met the inclusion criteria for the study. Comparing these predictors, PCT had the best predictive value (sensitivity: 87.5%, specificity: 95.5%), closely followed by the EOS risk calculator (sensitivity: 81.16%, specificity: 93.92%). Multivariate logistic regression found that risk scores calculated by the EOS risk calculator had strong associations with EOS as an independent risk factor (odds ratio: 57.37, P < 0.05). The combination of the EOS risk calculator, PCT, CBC and CRP could increase the predictive value of the model and reach an area under the receiver operating characteristic curve of 0.987 for predicting EOS. CONCLUSIONS: In this pilot study, applying the EOS calculator in China, the EOS risk calculator and PCT showed good predictive value compared to CBC and CRP. Risk scores from the EOS risk calculator strongly correlated with EOS, and the EOS risk calculator offered increased predictive value when used in combination with blood biomarkers.

Acute Funisitis Correlates With the Risk of Early-Onset Sepsis in Term Newborns Assessed Using the Kaiser Sepsis Calculator.

BACKGROUND: The risk of neonatal early-onset sepsis (EOS) is traditionally assessed on maternal signs of clinical chorioamnionitis. Recently, an online EOS risk calculator was developed by Kaiser Permanente using maternal and neonatal clinical parameters. We were interested in whether an increased Kaiser sepsis risk score correlates with histologic acute chorioamnionitis or acute funisitis. DESIGN: Included in this retrospective review are 119 chorioamnionitis-exposed term neonates from January 1, 2015 and December 31, 2016. Clinical charts from mother-baby pairs were reviewed. An EOS risk score was obtained using the online Kaiser Sepsis Calculator. The presence and severity of acute chorioamnionitis and acute funisitis were recorded. A SPSS software was used for statistical analysis (IBM, New Jersey, USA). RESULTS: The Kaiser Sepsis Calculator could identify 97 of 119 (81.5%) neonates without increased risk for sepsis. Histologic acute chorioamnionitis was present in 100 of 119 cases (84%), in which 44 cases (44%) show severe acute chorioamnionitis. Acute funisitis was recognized in 87 of 119 (73.1%) cases, all of which had concurrent acute chorioamnionitis. Severe funisitis was seen in 38 of the 87 cases (43.7%). The Kaiser Sepsis risk score correlates with the presence and severity of acute funisitis (P = .037 and P = .044, respectively) but not with the presence or the severity of acute chorioamnionitis (P = .105 and P = .672, respectively). CONCLUSION: Our study provides histological evidence to support that the Kaiser Sepsis Calculator may help to effectively reduce unwarranted blood culture, antibiotics exposure, and neonatal intensive care unit admission in term neonates.

Sepsis calculator implementation reduces empiric antibiotics for suspected early-onset sepsis.

Significant overtreatment with antibiotics for suspected early onset sepsis (EOS) constitutes a persisting clinical problem, generating unnecessary risks, harms, and costs for many newborns. We aimed to study feasibility and impact of a sepsis calculator to help guide antibiotic for suspected EOS in a European setting. In this single-center study, the sepsis calculator was implemented as an addition to and in accordance with existing protocols. One thousand eight hundred seventy-seven newborns ≥ 35 weeks of gestational age were prospectively evaluated; an analogous retrospective control group (n = 2076) was used for impact analysis. We found that empirical treatment with intravenous antibiotics for suspected EOS was reduced from 4.8 to 2.7% after sepsis calculator implementation (relative risk reduction 44% (95% confidence interval 21.4-59.5%)). No evidence for changes in time to treatment start, treatment duration, or proven sepsis rates was found. Adherence to sepsis calculator recommendation was 91%. CONCLUSION: Pragmatic and feasible implementation of the sepsis calculator yields a 44% reduction of empirical use of antibiotics for EOS, without signs of delay or prolongation of treatment. These findings warrant a multicenter, nation-wide, randomized study evaluating systematic use of the sepsis calculator prediction model and its effects in clinical practice outside of the USA. What is known: • Significant overtreatment with antibiotics for suspected early-onset sepsis results in unnecessary costs, risks, and harms. • Implementation of the sepsis calculator in the USA has resulted in a significant decrease in empirical antibiotic treatment, without apparent adverse events. What is new: • Implementation of the sepsis calculator in daily clinical decision-making in a Dutch teaching hospital is feasible in conjunction with existing protocols, with high adherence. • Antibiotic therapy for suspected early-onset sepsis was reduced by 44% following implementation of the calculator.

Neonatal early-onset sepsis calculator: Impact on antibiotic use in a level II neonatal unit in Western Australia.

BACKGROUND: Overuse of empirical intravenous antibiotics in neonates in high-income countries (HICs) is well documented. The Kaiser Permanente neonatal early-onset sepsis (EOS) calculator is an evidence-based sepsis risk assessment tool that has demonstrated potential to reduce antibiotic usage in this population. The incidence of early-onset sepsis in most HICs is 0.4-0.8 per 1000 live births. The objective was to evaluate the calculator's impact on antibiotic rates and length of stay in a regional level II Special Care Nursery. METHODS: A single-centre retrospective cohort study compared antibiotic administration rates in the first 72 h in neonates ≥35 weeks gestation born during two 6-month periods in 2019 (pre-EOS calculator) and 2021 (post-EOS calculator). Electronic and paper case records were accessed to capture data. Continuous data were summarised using mean and standard deviation, and categorical data were summarized using frequency distributions. There were 951 (2019) and 1129 (2021) infants born during the study periods. RESULTS: Following implementation of the calculator, antibiotic exposure decreased from 13.7% to 4.7% of all neonates without reported negative outcomes. Mean length of stay for neonates born across the two periods decreased from 2.38 to 2.13 days. Indications for antibiotic use shifted more towards clinical condition and away from obstetric risk factors. There were no culture-proven cases of sepsis or readmissions with EOS in either period. CONCLUSION: Implementation of the EOS calculator significantly reduced exposure to antibiotics, without adverse outcomes.

Diagnosis and Management of Neonatal Bacterial Sepsis: Current Challenges and Future Perspectives.

Sepsis remains the second cause of death among neonates after the pathological consequences of extreme prematurity. In this review we summarized knowledge about pathogens causing early-onset sepsis (EOS) and late-onset sepsis (LOS), the role of perinatal risk factors in determining the EOS risk, and the tools used to reduce unnecessary antibiotics. New molecular assays could improve the accuracy of standard blood cultures, providing the opportunity for a quick and sensitive tool. Different sepsis criteria and biomarkers are available to date, but further research is needed to guide the use of antibiotics according to these tools. Beyond the historical antibiotic regimens in EOS and LOS episodes, antibiotics should be based on the local flora and promptly modulated if specific pathogens are identified. The possibility of an antibiotic lock therapy for central venous catheters should be further investigated. In the near future, artificial intelligence could help us to personalize treatments and reduce the increasing trend of multidrug-resistant bacteria.

Antibiotic Management for Early-Onset Sepsis in Neonates With Gestational Ages of ≥ 34 Weeks: The Kaiser Sepsis Calculator Versus the 2010 CDC Guidelines.

INTRODUCTION: The traditional approach to neonatal early-onset sepsis (NEOS) management, involving maternal risk factors and nonspecific neonatal symptoms, usually leads to unnecessary antibiotic use. This study addresses these concerns by evaluating the Kaiser sepsis calculator (KSC) in guiding antibiotic therapy for NEOS, especially in high-incidence facilities (over 4/1,000 live births), by comparing it against the 2010 Centers for Disease Control and Prevention (CDC) guidelines for neonates ≥34 weeks with suspected sepsis, thereby emphasizing its implications for personalized patient care. METHODS: This is a prospective observational study. All neonates of 34 gestational weeks or more, presenting with either maternal risk factors or sepsis symptoms within 12 hours of birth, were included in the study. The analysis focused on antibiotic recommendations by the 2010 CDC guidelines versus those by the KSC at presumed (0.5/1,000) and actual (16/1,000) sepsis incidence rates. RESULTS: NEOS was identified in 14 cases (14.1%). Compared to the KSC, at an incidence rate of 16 per 1,000, the KSC resulted in a significant 32.3% reduction in antibiotic treatment (74 cases (74.7%) vs. 42 cases (42.4%), respectively; p < 0.001). The calculator advised immediate antibiotic utilization for 13 out of 14 (92.9%) diagnosed cases, suggesting further evaluation for the remaining cases. When a presumed incidence of 0.5/1,000 was applied, the KSC indicated antibiotics less frequently than when using the actual rate of 16/1,000 (p<0.001) with two missed NEOS cases. CONCLUSIONS: Using the KSC led to a decrease of 32 cases (32.3%) in unnecessary antibiotic prescriptions compared to adherence to 2010 CDC guidelines. However, setting a presumed incidence below the actual rate risked missing NEOS. The calculator was effective when actual local incidence rates were used, ensuring no missed cases needing antibiotics.

Barriers and Facilitators to the Implementation of the Early-Onset Sepsis Calculator: A Multicenter Survey Study.

Prior studies demonstrated the neonatal early-onset sepsis (EOS) calculator's potential in drastically reducing antibiotic prescriptions, and its international adoption is increasing rapidly. To optimize the EOS calculator's impact, successful implementation is crucial. This study aimed to identify key barriers and facilitators to inform an implementation strategy. A multicenter cross-sectional survey was carried out among physicians, residents, nurses and clinical obstetricians of thirteen Dutch hospitals. Survey development was prepared through a literature search and stakeholder interviews. Data collection and analysis were based on the Consolidated Framework for Implementation Research (CFIR). A total of 465 stakeholders completed the survey. The main barriers concerned the expectance of the department's capacity problems and the issues with maternal information transfer between departments. Facilitators concerned multiple relative advantages of the EOS calculator, including stakeholder education, EOS calculator integration in the electronic health record and existing positive expectations about the safety and effectivity of the calculator. Based on these findings, tailored implementation interventions can be developed, such as identifying early adopters and champions, conducting educational meetings tailored to the target group, creating ready-to-use educational materials, integrating the EOS calculator into electronic health records, creating a culture of collective responsibility among departments and collecting data to evaluate implementation success and innovation results.

Management of well appearing infants born to afebrile mothers with inadequate GBS prophylaxis: A retrospective comparison of the three approaches recommended by the COFN.

BACKGROUND: There are three different approaches set forth by the Committee on the Fetus and Newborn (COFN) for managing asymptomatic neonates born to mothers with inadequate intrapartum antibiotic prophylaxis (IAP) for early-onset Group B Strep (GBS) infection. The first approach is that of categorical risk factor assessments, and recommends that asymptomatic infants born to afebrile mothers with inadequate IAP for GBS be monitored with clinical observation for 36-48 hours. The second approach recommends serial physical examinations and vital signs for 36-48 hours to closely monitor changes in clinical condition for all patients. The Kaiser Permanente EOS risk calculator (SRC) is an example of the third approach, a multivariate risk assessment, and it takes into consideration several perinatal risk factors. This multivariate risk assessment then provides recommendations for reassessment and management based on presume risk of the infant developing or having Early Onset Sepsis (EOS). The aim of our study was to compare these three recently published recommendations from the COFN for the management of asymptomatic neonates born to afebrile mothers with inadequate IAP for GBS. STUDY DESIGN: This is a retrospective study of asymptomatic neonates with gestational age ≥35 weeks born to afebrile mothers with indicated inadequate IAP for GBS between April 2017 and July 2020. Management recommendations of the SRC were compared to the recommendations of categorical risk assessment and risk assessment based on clinical condition. RESULTS: A total of 7,396 infants were born during the study period, 394 (5.3%. to mothers with inadequate IAP. Recommendations for these infants according to both the categorical risk factor guideline and the clinical condition guideline include extended, close observation. However, the SRC recommended routine newborn care for 99.7%.f these infants. None of the infants developed EOS. CONCLUSION: The SRC recommend routine neonatal care without enhanced and prolonged observation for nearly all asymptomatic infants born to afebrile mothers with inadequate IAP. As none of the infants in this cohort had EOS, further studies in a larger cohort are needed to establish the safety of SRC in neonates born to mothers with inadequate IAP.

Neonatal early-onset infections: Comparing the sensitivity of the neonatal early-onset sepsis calculator to the Dutch and the updated NICE guidelines in an observational cohort of culture-positive cases.

BACKGROUND: The early-onset sepsis calculator (EOSC) reduces unnecessary antibiotic treatment in newborns. However, its performance in identifying cases with early-onset disease (EOD) is unclear. We compared the sensitivity of the EOSC to the current Dutch and National Institute for Health and Care Excellence (NICE) guidelines when applied to a cohort of newborns with culture-positive early-onset sepsis and meningitis. METHODS: Culture-positive Streptococcus agalactiae (GBS) and Escherichia coli (E. coli) sepsis and meningitis patients ≤3 days old with a gestational age ≥34 weeks, identified between 1/1/2018 and 31/1/2021 in a Dutch prospective nationwide cohort study were included. Cases were identified by treating physicians and microbiological surveillance. Primary outcome was the proportion of patients that would have been treated according to the EOSC, the Dutch, and the NICE EOD prevention guidelines. Differences between proportions were analysed using McNemar's test. FINDINGS: We included 81 GBS and 7 E. coli EOD cases. At 4 h after birth, the EOSC would have recommended antibiotic treatment in 32 (36%) patients, compared to 44 (50%) by the Dutch (p<0·01) and 48 (55%) by the NICE guideline (p<0·01). The EOSC would have initially recommended routine care for 52% of patients compared to 31% and 30% for the Dutch and NICE guidelines (p<0·01). At 24 h after birth, the EOSC would have recommended antibiotic treatment in 54 (61%) infants compared to 64 (73%) by the Dutch (p = 0·02) and 63 (72%) by the NICE guidelines (p = 0·06). INTERPRETATION: The sensitivity of the EOSC in identifying cases of EOD is lower compared to both Dutch and NICE guidelines, especially directly after birth. The EOSC relies more on clinical symptoms and results in less overtreatment of healthy newborns at the cost of later antibiotic treatment in initially well-appearing EOD patients. FUNDING: This work was supported by grants received from Netherlands Organization for Health Research and Development (ZonMw; NWO-Vidi-Grant (grant number 917·17·308); NWO-Vici-Grant (grant number 918·19·627)), the Academic Medical Centre (AMC Innovative Impulse Grant) and Steun Emma Foundation Grant.

Introduction of the neonatal sepsis calculator at a low-dependency special care nursery in Australia.

BACKGROUND: The neonatal early onset sepsis calculator (Sepsis Calculator) is a screening tool for managing neonates at risk of early onset sepsis (EOS). In large tertiary centers it has been found to reduce empiric antibiotic use in newborns with suspected EOS by up to half, without missing EOS confirmed by blood culture. AIMS: To evaluate the effect of implementation of the Sepsis Calculator at a low-dependency special care nursery in Australia on rates of antibiotic treatment for suspected EOS in newborns, and, to determine the compliance rate in applying the Sepsis Calculator. METHODS: We undertook a retrospective medical record audit at The Women's at Sandringham Hospital during two two-month periods; pre- and post-introduction of the Sepsis Calculator. The management of infants suspected of EOS and length of stay post-delivery were compared. Compliance with Sepsis Calculator use was measured. RESULTS: 526 infants were included: 266 in period 1 and 260 in period 2. There was no significant change in the proportion of infants who received empirical antibiotics for suspected EOS following introduction of the Sepsis Calculator (6 of 266 during period 1; 2.2% vs. 8 of 260 during period 2; 3.1%; p = .558). The median length of stay (LOS) of infants born to GBS positive mothers who received inadequate antibiotic prophylaxis, decreased from 39.5 h (IQR 28.4 to 47.4) to 25.5 h (IQR 22.2 to 34.2), p = .004 after Sepsis Calculator implementation. The compliance rate for Sepsis Calculator use was 82.3% (214 of 260). CONCLUSIONS: While we did not see a reduction in empirical antibiotic use, this is likely due to the already low baseline antibiotic treatment rate at our institution. Further exploration of how the calculator benefits infants and improves care in non-tertiary special care nurseries, including evaluating LOS, is needed.

Should we give antibiotics to neonates with mild non-progressive symptoms? A comparison of serial clinical observation and the neonatal sepsis risk calculator.

Objective: To compare two strategies [the neonatal sepsis risk calculator (NSC) and the updated serial clinical observation approach (SCO)] for the management of asymptomatic neonates at risk of early-onset sepsis (EOS) and neonates with mild non-progressive symptoms in the first hours of life. Methods: This was a single-center, retrospective cohort study conducted over 15 months (01/01/2019-31/03/2020). All live births at ≥34 weeks of gestation were included. Infants were managed using SCO and decisions were compared with those retrospectively projected by the NSC. The proportion of infants recommended for antibiotics or laboratory testing was compared in both strategies. McNemar's non-parametric test was used to assess significant differences in matched proportions. Results: Among the 3,445 neonates (late-preterm, n = 178; full-term, n = 3,267) 262 (7.6%) presented with symptoms of suspected EOS. There were no cases of culture-proven EOS. Only 1.9% of the neonates were treated with antibiotics (median antibiotic treatment, 2 days) and 4.0% were evaluated. According to NSC, antibiotics would have been administered in 5.4% of infants (absolute difference between SCO and NSC, 3.51%; 95% CI, 3.14-3.71%; p <0.0001) and 5.6% of infants would have undergone "rule out sepsis" (absolute difference between SCO and NSC, 1.63%, 95% CI 1.10-2.05; p <0.0001). Conclusion: SCO minimizes laboratory testing and unnecessary antibiotics in infants at risk of EOS or with mild non-progressive symptoms, without the risk of a worse neonatal outcome. The NSC recommends almost three times more antibiotics than the SCO without improving neonatal outcomes.

Early-onset sepsis: can we screen fewer babies safely?

BACKGROUND: Over the past 2-3 years at the Southwest Peninsula tertiary neonatal unit in Plymouth, the authors have observed an increase in the number of clinically well term infants being screened and treated with antibiotics for infection in accordance with NICE guidance. The aim of our study was to assess the safety of implementing the Kaiser Permanente Early Onset Sepsis (KPEOS) calculator to minimise antibiotic usage in term infants in line with antimicrobial stewardship, reducing separation from mother at birth and facilitating earlier discharge. METHODS: A 2-year retrospective review of medical records from 2014 to 2015 inclusive revealed 9217 deliveries, with 1550 infants (16.8%) having risk factors, 945 (10.2%) being term infants. Of those, 507 (53.6%) had a clinical reason to screen and 438 (46.4%) had risk factors alone treated with antibiotics for variable periods of time. This enabled us to review our usual practice and compare it with our KPEOS implementation. INTERVENTION: National Health Service England permission was obtained to implement the KPEOS for a 6-month period. We collected data on all 175 term infants with risk factors to compare with our previous practice when The National Institute for Health and Care Excellence and Royal College of Obstetrics and Gynaecology maternal guidance was being followed. RESULTS: The percentage of infants screened with a suspected infection previously receiving 5 days of antibiotics reduced from 31% (136/438) to 5% (9/157, p<0.0001) using the KPEOS calculator. Clinically well infants with risk factors alone previously receiving 36 hours of antibiotics, reduced from 63% (275/438) to 3% (5/157, p<0.0001) of infants treated. There was no late-onset sepsis in this study cohort or any observed adverse outcomes. CONCLUSION: These results demonstrated a potentially safe and effective quality improvement (QI) in our hospital with fewer babies treated and a reduced length of stay for this cohort. Considering individual hospitals rates for term Group B Streptococcal sepsis, this QI may be a safe and economical alternative to current practices for screening well term infants.

Sepsis calculator for neonatal early onset sepsis - a systematic review and meta-analysis.

BACKGROUND: Over investigation and overuse of empirical antibiotics is a concern in management of neonatal early onset sepsis (EOS) using the Centers for Disease Control and Prevention guidelines. "Sepsis calculator" is a risk-based prediction model for managing neonates at risk of EOS. OBJECTIVE: To compare outcomes of neonatal EOS using of sepsis calculator versus conventional approach. METHODS: A systematic review of randomized controlled trials (RCT) and non-RCTs reporting on outcomes after implementation of sepsis calculator for EOS for neonates >34-week gestation was conducted using the Cochrane methodology. Databases PubMed, CINAHL, Embase, Cochrane Central library and Google Scholar were searched in May 2019. Primary outcomes were antibiotics usage and laboratory tests for managing EOS. Secondary outcomes included hospital admissions and readmissions, blood culture positive EOS and mortality. The level of evidence (LOE) was summarized using the GRADE guidelines. RESULTS: A total of 387 articles were retrieved after initial search. Six high quality non-RCTs fulfilled inclusion criteria. Meta-analysis (random effects model) showed that implementation of sepsis calculator was associated with reduced antibiotic usage [N = 172,385; OR = 0.22 (0.14-0.36); p < .00001; heterogeneity (I2) = 97%, Number needed to treat (NNT): 22], laboratory tests [N = 168,432; OR = 0.14 (0.08-0.27); p < .00001; I2 = 99%, NNT = 8], and admissions to neonatal unit [N = 16,628; OR = 0.24 (0.11-0.51); p = .0002; I2 = 98%, NNT = 7]; LOE: moderate. There was no difference in mortality, culture positive EOS, and readmissions. CONCLUSION: Moderate quality evidence indicates that the implementation of a sepsis calculator was associated with reduced usage of antibiotics, laboratory tests and admission to neonatal unit with no increase in mortality and readmissions.

Management of infants born to mothers with chorioamnionitis: A retrospective comparison of the three approaches recommended by the committee on fetus and newborn.

BACKGROUND: Based on the most recently published recommendations from the Committee on the Fetus and Newborn (COFN), three approaches currently exist for the use of risk factors to identify infants who are at increased risk of early-onset sepsis (EOS). Categorical risk factor assessments recommend laboratory testing and empiric antibiotic therapy for all infants born to mothers with a clinical diagnosis of chorioamnionitis. Risk assessments based on clinical condition recommend frequent examinations and close vital sign monitoring for infants born to mothers with chorioamnionitis. The Kaiser Permanente EOS risk calculator (SRC) is an example of the third approach, multivariate risk assessments. The aim of our study was to compare the three risk stratification approaches recommended by the COFN for management of chorioamnionitis-exposed infants. METHODS: Retrospective study of 1,521 infants born ≥35 weeks to mothers with chorioamnionitis. Management recommendations of the SRC were compared to the recommendations of categorical risk assessment and risk assessment based on clinical condition (CCA). RESULTS: Hypothetical application of SRC and CCA resulted in 79.6% and 76.8-85.1% respectively fewer infants allocated empiric antibiotic therapy. While CCA recommended enhanced observation for all chorioamnionitis-exposed infants, SRC recommended routine care without enhanced observation in 44.3% infants. For the six infants (0.39%) with EOS, SRC and CCA recommended empiric antibiotics only for three symptomatic infants. CONCLUSION: The SRC and CCA can reduce antibiotic use but potentially delay antibiotic treatment. The SRC does not recommend enhanced observation with frequent and prolonged vital signs for >44% of chorioamnionitis-exposed infants.

Application of Kaiser Sepsis Calculator in culture-positive infants with early onset sepsis.

BACKGROUND: Kaiser Sepsis Calculator (KSC) reduces antibiotic use, testing and intravenous infiltrates but there are concerns about the missed early onset sepsis (EOS) cases. We sought to apply the KSC score for culture-positive infants retrospectively in infants born in the last 10 years in our hospital. METHODS: In a retrospective cohort study, the comparison groups were divided into Group A (no antibiotics recommended by KSC) and Group B (antibiotics recommended). RESULTS: Overall, 17/24 (71%) infants would have been started on antibiotics per KSC but 7/24 (29%) would not. The initial EOS risk was not significantly different between the groups (Group A vs. Group B: 0.44 vs. 0.76, P = 0.41), but the final risk score was (0.33 vs. 9.41, P < 0.001). In Group A (no antibiotics), 3/7 infants became symptomatic between 9 and 42 hours. CONCLUSION: There may be a potential delay in starting antibiotics in infants that are asymptomatic at birth while using KSC.

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

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.