Background: Neonates admitted to neonatal intensive care units (NICUs) face a significant risk of contracting nosocomial infections. Cefepime is a broad-spectrum fourth-generation cephalosporin being used in unstable, critically ill neonates. To date, no neonatal data describing clinical outcomes with cefepime exist. The objective of this study was to characterize the clinical outcomes with cefepime in a neonatal intensive care population.

Methods: Preterm and term neonates receiving cefepime for at least 48 hrs between January 1, 2010 and December 31, 2013 were included in the study. Cefepime courses could occur at any time between birth and 48 wks post-menstrual age. Demographic, cefepime regimen, culture and susceptibility, and documented adverse effect (AE) data were extracted from medical records. Courses were categorized as having positive clinical response if, while on cefepime, the patient experienced 1) normalization of a previously elevated leukocyte count and/ or 2) negative follow-up cultures. Renal impairment was defined as a serum creatinine increase of 50 percent or greater above baseline or a urine output of less than 1 mL/kg/hr.

Results: Final analysis included 74 patients who received 105 cefepime treatment courses. Patients had a mean (SD) gestational age (weeks) of 29.7 (5.8), and 63.5% (47/74) were male. The mean (SD) empiric cefepime dose was 36 ± 12.9 mg/ kg/dose every 12 hrs, and cefepime was most commonly used for late-onset sepsis (39%). Clinical response was evaluable in 49.5% (52/105) courses. In these courses, positive clinical response was observed in 73.1% (38/52). Overall patient mortality was 23% (17/74). There were 18 AE potentially attributable to cefepime occurring in 14.3% (15/105) of courses. Acute kidney injury was observed in 17.1% (18/105) of courses.

Conclusion: Cefepime was used safely with reasonable clinical response in this NICU cohort, but additional studies are needed to further determine cefepime-associated clinical outcomes.