ABSTRACT
OBJECTIVE: Neonatal bacterial infections carry a high mortality when diagnosed late. Early diagnosis is difficult because initial clinical signs are nonspecific. Consequently, physicians frequently prescribe antibiotic treatment to newborn infants for fear of missing a life-threatening infection. This study was designed to test the hypotheses that a diagnostic algorithm that includes measurements of interleukin 8 (IL-8) and C-reactive protein (CRP) 1) reduces antibiotic therapy and 2) does not result in more initially missed infections compared with standard management that does not include an IL-8 measurement. METHODS: Term and preterm infants who were <72 hours of age and had clinical signs or obstetric risk factors suggesting neonatal bacterial infection but stable enough to wait for results of diagnostic tests were enrolled into the study. A total of 1291 infants were randomly assigned to receive antibiotic therapy according to the guidelines of each center (standard group) or to receive antibiotic therapy when IL-8 was >70 pg/mL and/or CRP was >10 mg/L (IL-8 group). The primary outcome variables were 1) the number of infants treated with antibiotics and 2) the number of infants with infections missed at the initial evaluation. RESULTS: In the IL-8 group, fewer infants received antibiotic therapy than in the standard group (36.1% [237 of 656] vs 49.6% [315 of 635]). In the IL-8 group, 24 (14.5%) of 165 infants with infection were not detected at the initial evaluation, compared with 28 (17.3%) of 162 in the standard group. CONCLUSIONS: The number of newborn infants who received postnatal antibiotic therapy can be reduced with a diagnostic algorithm that includes measurements of IL-8 and CRP. This diagnostic strategy seemed to be safe.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Bacterial Infections/diagnosis , C-Reactive Protein/analysis , Interleukin-8/blood , Algorithms , Bacterial Infections/blood , Bacterial Infections/drug therapy , Humans , Infant, Newborn , Infant, Premature , Infant, Premature, Diseases/diagnosis , Infant, Premature, Diseases/drug therapy , Sensitivity and Specificity , Unnecessary ProceduresABSTRACT
AIMS: To assess the usefulness of C-reactive protein (CRP) [either alone or in combination with a full blood examination (FBE) and microbiology of gastric aspirate] in predicting the diagnosis of neonatal sepsis compared with routinely available markers of infection. METHODS: A prospective study of quantitative CRP, FBE, gastric aspirate and surface swab microscopy and culture in predicting neonatal sepsis in a level III perinatal referral hospital was performed. RESULTS: Of 301 episodes evaluated over a 5-month period, there was a 5% rate of major (culture proven) sepsis (3% early onset, <72 hours) and 10% rate of modified sepsis. No single test alone was sufficiently reliable as an indicator of infection to be a satisfactory screening tool for early onset sepsis [CRP sensitivity 67%, negative predictive value (NPV) 86%, FBE sensitivity 63%, NPV 80%, gastric aspirate sensitivity 57%, NPV 83%]. CONCLUSION: The three-test combination had a sensitivity of 97%, NPV 98% and likelihood ratio of 49, thus providing a useful diagnostic tool.