AIMTo investigate whether serial physical examinations (SPEs) are a safe tool for managing neonates at risk for early-onset sepsis (EOS).METHODSThis is a retrospective cohort study of neonates (≥ 34 wks’ gestation) delivered in three high-volume level IIIbirthing centres in Emilia-Romagna (Italy) during a 4-mo period (from September 1 to December 31, 2015). Neonates at risk for EOS were managed according to the SPEs strategy, these were carried out in turn by bedside nursing staff and physicians. A standardized form detailing general wellbeing, skin colour and vital signs was filled in and signed at standard intervals (at age 3, 6, 12, 18, 36 and 48 h) in neonates at risk for EOS. Three independent reviewers reviewed all charts of neonates and abstracted data (gestational age, mode of delivery, group B streptococcus status, risk factors for EOS, duration of intrapartum antibiotic prophylaxis, postpartum evaluations, therapies and outcome). Rates of sepsis workups, empirical antibiotics and outcome of neonates at-risk (or not) for EOS were evaluated.RESULTSThere were 2092 live births and 1 culture-proven EOS (Haemophilus i) (incidence rates of 0.48/1000 live births). Most newborns with signs of illness (51 out of 101, that is 50.5%), and most of those who received postpartum antibiotics (17 out of 29, that is 58.6%) were not at risk for EOS. Compared to neonates at risk, neonates not at risk for EOS were less likely to have signs of illness (51 out of 1442 vs 40 out of 650, P = 0.009) or have a sepsis workup (25 out of 1442 vs 28 out of 650, P < 0.001). However, they were not less likely to receive empirical antibiotics (17 out of 1442 vs 12 out of 650, P = 0.3). Thirty-two neonates were exposed to intrapartum fever or chorioamnionitis: 62.5% (n = 20) had a sepsis workup and 21.9% (n = 7) were given empirical antibiotics. Among 216 neonates managed through the SPEs strategy, only 5.6% (n = 12) had subsequently a sepsis workup and only 1.9% (n = 4) were given empirical antibiotics. All neonates managed through SPEs had a normal outcome. Among 2092 neonates, only 1.6% (n = 34) received antibiotics; 1.4% (n = 29) were ill and 0.2% (n = 5) were asymptomatic (they were treated because of risk factors for EOS).CONCLUSIONThe SPEs strategy reduces unnecessary laboratory evaluations and antibiotics, and apparently does not worsen the outcome of neonates at-risk or neonates with mild, equivocal, transient symptoms.

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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.

ObjectiveTo 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.MethodsThis 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.ResultsAmong 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 &lt;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 &lt;0.0001).ConclusionSCO 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.

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