Abstract
BackgroundEarly-onset sepsis (EOS) is a potentially life-threatening complication of birth. Clinical symptoms are often unspecific and biomarkers have low predictive values for EOS. Therefore, clinical suspicion often leads to antibiotic therapy in neonates with a negative blood culture. In the study we evaluated if a quality improvement initiative could reduce unwarranted antibiotic use in a safe way in term neonates with culture-negative sepsis.MethodsThe quality improvement initiative included new treatment guidelines and were introduced on 11 June 2018. The guidelines included C-reactive protein- and clinical symptoms-guided decision-making and shorter intravenous antibiotic therapy. All term neonates treated for EOS at Ryhov Hospital, Jönköping, Sweden were studied before (period 1: 2016–2017) and after the introduction of the new guidelines (period 2: 11 June 2018 to 30 Sept 2019).Laboratory and clinical data were analysed.ResultsThere were 7618 term neonates in period 1 and 5005 term neonates in period 2. We identified 140 (1.8%) EOS in period 1 and 97 (1.9%) EOS in period 2. During period 1 and 2, there were 61 (61/140, 44%) and 59 (59/97, 61%) EOS neonates, respectively, who met the criteria for shorter antibiotic treatment. The number of positive blood cultures were seven (0.92/1000 live births) and five (1.0/1000 live births) in period 1 and 2. The median C-reactive protein were 52 mg/L (37–62) in period 1 and 42 mg/L (31–56) in period 2 in the group who met the criteria of the guidelines. The duration of antibiotic therapy (Median: seven vs. five days, p < 0.001) and hospital stay (Median: seven vs. five days, p < 0.001) as well as healthcare costs (decreased by €122,000/year) was reduced in the group who met the criteria after the introduction of the guidelines.ConclusionC-reactive protein- and clinical symptoms-guided decision-making for EOS significantly decreased the duration of antibiotic therapy and hospital stay, and hence reduced healthcare costs, with no reinfection in a cohort of term infants.Trial registrationTrial registration number: ISRCTN29535824. Date of registration: 28 May 2020. Retrospectively registered.
Highlights
Early-onset sepsis (EOS) is a potentially life-threatening complication of birth
C-reactive protein- and clinical symptoms-guided decision-making for EOS significantly decreased the duration of antibiotic therapy and hospital stay, and reduced healthcare costs, with no reinfection in a cohort of term infants
During period 1 we identified 185 term neonates who were admitted to the neonatal intensive care unit (NICU) in the first three days of life and treated with antibiotic therapy (Table 2)
Summary
Early-onset sepsis (EOS) is a potentially life-threatening complication of birth. Clinical symptoms are often unspecific and biomarkers have low predictive values for EOS. Clinical suspicion often leads to antibiotic therapy in neonates with a negative blood culture. In the study we evaluated if a quality improvement initiative could reduce unwarranted antibiotic use in a safe way in term neonates with culture-negative sepsis. Early-onset sepsis (EOS) is a potentially life-threatening complication of birth [1]. Delayed antimicrobial therapy of sepsis increases the risk of morbidity and mortality, making it important to recognise and diagnose sepsis early [2]. Clinical suspicion often leads to antibiotic therapy in uninfected neonates. The incidence of cultureconfirmed EOS among infants born at term is approximately 0.4–0.8 in 1000 live births in most high-income countries [7,8,9,10,11,12,13]. The number of neonates receiving antibiotic therapy for culture-negative sepsis is six to 16 times higher than neonates receiving therapy for culture-confirmed sepsis [13]
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