Serial physical examinations, a simple and reliable tool for managing neonates at risk for early-onset sepsis

Abstract

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.

Clinical Monitoring of Well-Appearing Infants Born to Mothers With Chorioamnionitis

“…Another study using clinical examination to determine the need for antibiotics in infants who are at risk for sepsis did not demonstrate an increased risk of readmission after hospital discharge. 20 Finally, the sample size in this study was small, especially in light of the low incidence of EOS. Consistent with the epidemiology of chorioamnionitis, we also had a low representation of late-preterm infants in our cohort.…”

“…Cantoni et al 21 found no difference in clinical outcomes in term infants who were monitored with serial physical examinations versus those who additionally received laboratory testing. Berardi et al 20 noted fewer laboratory tests, less antibiotic use, and unchanged outcomes in at-risk infants ≥34 weeks' gestation when solely using serial physical examinations. In addition, the NSC has recently been updated to factor in the clinical presentation of the infant in the sepsis risk score before any treatment decisions are made.…”

“…The updated approach was guided by (1) the low risk of EOS in well-appearing late-preterm and term infants regardless of risk factors, 1,7,8,11,16,17 (2) the limited clinical utility of CBC counts and C-reactive proteins (CRPs) to guide antibiotic treatment decisions in well-appearing infants, 15,18,19 and (3) the potential utility of clinical examination to identify EOS in at-risk infants. 20,21 Our specific aim was to reduce unnecessary antibiotic exposure and laboratory testing in well-appearing, late-preterm and term, chorioamnionitis-exposed infants. The objective of the current quality-improvement (QI) report was to evaluate the impact of the new care approach after the first 15 months of implementation.…”

Are postnatal ampicillin levels actually related to the duration of intrapartum antibiotic prophylaxis prior to delivery? A pharmacokinetic study in 120 neonates

“…The full administration of each dose is usually reached within 15 min. According to our local protocol, asymptomatic neonates ≥35 weeks of gestation exposed to inadequate IAP undergo serial physical examinations without any laboratory evaluation or empirical antibiotics 16. The study protocol was approved by the local ethical committee (Protocol no 159/13).…”

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

“…Every suspected clinical sign of EOS is immediately notified to the clinician. In a retrospective study carried out in 3 Italian centers [9], 2,092 full-term and late-preterm neonates were managed with SPEs. Among 632 initially asymptomatic neonates at risk of EOS, only 3% were evaluated (0.9% of the entire cohort), and only 1.1% (0.3% of the entire cohort) were given empirical antibiotics.…”