Sustainability of a Clinical Examination-Based Approach for Ascertainment of Early-Onset Sepsis in Late Preterm and Term Neonates

doi:10.1016/j.jpeds.2020.05.055

The Journal of Pediatrics

Volume 225, October 2020, Pages 263-268

https://doi.org/10.1016/j.jpeds.2020.05.055 Get rights and content

We demonstrated the sustained impact over a 5-year period of a clinical examination-based approach to identification of early-onset sepsis in late preterm and term neonates at our hospital. To date, more than 20 000 neonates have been safely managed using this approach, resulting in a 63% reduction in antibiotic use.

Section snippets

Methods

Lucile Packard Children's Hospital at Stanford is a freestanding, tertiary-care children's hospital with approximately 4500 deliveries annually. Routine newborn care includes couplet care for the mother and neonate with both rooming together in the postpartum unit (ie, newborn nursery). A level II-IV neonatal intensive care unit (NICU) is located adjacent to the postpartum unit. An in-house neonatal hospitalist is available 24 hours per day to attend all high-risk deliveries and evaluate

Results

Since the start of our QI practice change in March 2015, a total of 20 394 neonates at ≥35 weeks of gestation were born at our hospital and followed using a clinical examination-based approach for EOS. The percentage of neonates exposed to ampicillin (Figure, A) decreased from 11.1% in the pre-QI period (373 of 3355) to 4.1% in the QI period (837 of 20 394; P < .001). The use of ampicillin during the sustainability phase of the QI period (3.7%; 370 of 9886) was lower than that in phase I (4.8%;

Discussion

Here we describe the ongoing impact of a clinical examination-based approach for EOS management in late preterm and term neonates at our hospital. Over a period of almost 5 years, implementation of this approach has reduced the use of antibiotics by 63% and reduced sepsis laboratory testing by 59%. The change in practice has been sustained with continuing low rates of antibiotic use and sepsis laboratory testing over the most recent ∼30 months of evaluation. The current report adds to previous

Data Statement

Data sharing statement available at www.jpeds.com.

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Cited by (20)

Improved efficiency in the management of newborns with infectious risk factors by the sepsis risk calculator and clinical observation
2024, Jornal de Pediatria
To evaluate the efficiency of the sepsis risk calculator and the serial clinical observation in the management of late preterm and term newborns with infectious risk factors.
Single-center, observational, two-phase cohort study comparing the rates of neonates born ≥35 weeks' gestation, ≥2000 g birthweight, and without major congenital anomalies, who were screened and/or received antibiotics for early-onset neonatal sepsis risk at our center during two periods, before (January/2018–June/2019) and after (July/2019–December/2020) the implementation of the sepsis risk calculator.
A total of 1796 (Period 1) and 1867 (Period 2) patients with infectious risk factors were included. During the second period, tests to rule out sepsis were reduced by 34.0 % (RR, 95 %CI): 0.66 (0.61, 0.71), blood cultures by 13.1 %: 0.87 (0.77, 0.98), hospital admissions by 13.5 %: 0.86 (0.76, 0.98) and antibiotic administration by 45.9 %: 0.54 (0.47, 0.63). Three cases of early-onset neonatal sepsis occurred in the first period and two in the second. Clinical serial evaluation would have detected all true cases.
The implementation of a sepsis risk calculator in the management of newborns ≥35 weeks GA, ≥2000 g birthweight, without major congenital anomalies, with infectious risk factors is safe and adequate to reduce laboratory tests, blood cultures, hospital admissions, and antibiotics administration. Serial clinical observation, in addition, could be instrumental to achieve or even improve this goal.
Game changer or gimmick: inflammatory markers to guide antibiotic treatment decisions in neonatal early-onset sepsis
2024, Clinical Microbiology and Infection
The diagnosis of neonatal early-onset sepsis (EOS) is challenging, and inflammatory markers are widely used to guide decision-making and therapies.
This narrative review presents the current state of knowledge regarding the diagnostic value and potential pitfalls in the interpretation of inflammatory markers for EOS.
PubMed until October 2022 and searched references in identified articles using the search terms: neonatal EOS, biomarker or inflammatory marker, and antibiotic therapy or antibiotic stewardship.
In situations with a high or low probability of sepsis, the measurements of inflammatory markers have no impact on the decision to start or stop antibiotics and are just gimmick, whereas they may be a game changer for neonates with intermediate risk and therefore an unclear situation. There is no single or combination of inflammatory markers that can predict EOS with high probability, allowing us to make decisions regarding the start of antibiotics based only on inflammatory markers. The main reason for the limited accuracy is most probably the numerous noninfectious conditions that influence the levels of inflammatory markers. However, there is evidence that C-reactive protein and procalcitonin have good negative predictive accuracy to rule out sepsis within 24 to 48 hours. Nevertheless, several publications have reported more investigations and prolonged antibiotic treatments with the use of inflammatory markers. Given the limitations of current strategies, using an algorithm with only moderate diagnostic accuracy may have a positive impact, as reported for the EOS calculator and the NeoPInS algorithm.
As the decision regarding the start of antibiotic therapy is different from the process of stopping antibiotics, the accuracy of inflammatory markers needs to be evaluated separately. Novel machine learning-based algorithms are required to improve accuracy in the diagnosis of EOS. In the future, inflammatory markers included in algorithms may be a game changer reducing bias and noise in the decision-making process.
Results of a strategy based on clinical observation of newborns at risk of early-onset neonatal sepsis
2023, Early Human Development
Serial clinical observation of asymptomatic newborns at risk of early-onset sepsis is an alternative option for which there is limited scientific evidence.
To evaluate the rate of protocol compliance, the impact on blood tests, percentage of hospitalizations and subsequent procedures, and course of diagnosed early-onset sepsis cases of a protocol based on serial clinical observation.
Retrospective observational study comparing an 18-month period under this protocol against a previous protocol based on laboratory tests. Subjects: 6895 asymptomatic newborns with over 35 weeks of gestation. Outcome measures: number of evaluations performed on each subject at risk, percentage of patients undergoing blood draws and hospitalization rates.
Some of the evaluations included in the protocol were omitted in 51.6 % of the newborns undergoing the physical examinations. The implementation of this new approach was associated with a decrease in the percentage of patients undergoing blood draws from 16.8 % to 0.7 % (p < 0.001) with no differences in the progression of the five cases of sepsis studied in each period. The serial clinical observation protocol was associated with a significant increase in hospitalizations for suspected infection, although with no difference in the rate of lumbar punctures performed or antibiotic treatments administered.
Compliance with the serial clinical observation protocol can be difficult. This approach often detects newborns with abnormal clinical data that are not explained by early-onset sepsis. Clinical observation is a safe option that minimizes the rate of blood draws.
Prevention of Necrotizing Enterocolitis
2022, Clinics in Perinatology
Proposing a care practice bundle for neonatal encephalopathy during therapeutic hypothermia
2021, Seminars in Fetal and Neonatal Medicine
Neonates with neonatal encephalopathy (NE) often present with multi-organ dysfunction that requires multidisciplinary specialized management. Care of the neonate with NE is thus complex with interaction between the brain and various organ systems. Illness severity during the first days of birth, and not only during the initial hypoxia-ischemia event, is a significant predictor of adverse outcomes in neonates with NE treated with therapeutic hypothermia (TH). We thus propose a care practice bundle dedicated to support the injured neonatal brain that is based on the current best evidence for each organ system. The impact of using such bundle on outcomes in NE remains to be demonstrated.
The Term Newborn: Early-Onset Sepsis
2021, Clinics in Perinatology
Citation Excerpt :
In data from an earlier era, no cases of meningitis were identified among 284 asymptomatic infants who underwent lumbar puncture because of maternal risk factors.51 The proportion of term infants who are treated for suspected EOS in contemporary studies and found to be bacteremic is at present less than 1%.33,44 In most cases, therefore, and definitively among well-appearing term infants, lumbar puncture can be deferred until blood culture yields a pathogen.

View all citing articles on Scopus

: A.F. is a scientific consultant for Takeda Pharmaceuticals. The other authors declare no conflicts of interest.

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Brief ReportsSustainability of a Clinical Examination-Based Approach for Ascertainment of Early-Onset Sepsis in Late Preterm and Term Neonates

Section snippets

Methods

Results

Discussion

Data Statement

Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC

MMWR Recomm Rep

Prevention of perinatal group B streptococcal disease: revised guidelines from CDC, 2010

MMWR Recomm Rep

A quantitative, risk-based approach to the management of neonatal early-onset sepsis

JAMA Pediatr

Group B Streptococcus early-onset disease and observation of well-appearing newborns

PLoS One

Neonatal sepsis of early onset, and hospital-acquired and community-acquired late onset: a prospective population-based cohort study

J Pediatr

Brief Reports
Sustainability of a Clinical Examination-Based Approach for Ascertainment of Early-Onset Sepsis in Late Preterm and Term Neonates