Efficacy of a Triple Anti-Infective Regimen for Prevention of Complications in Critically Ill Term Neonates

Background: Aim of the study was to analyze the use of a prophylactic multimodal anti-infective regimen including the probiotic Lactobacillus casei rhamnosus (LCR35) in critically ill term neonates with respect to complications and possible side effects. Methods: This was a retrospective observational STROBE compliant single-center cohort study of all term infants born between 2005 and 2015 that have been admitted within the first 24 hours of life to the neonatal intensive care unit (NICU) and having been hospitalized for at least 7 days. All neonates received a standardized prophylactic anti-infective treatment with enteral probiotics (LCR35), antifungal agents, and oral gentamycin over the study time starting at the first day of life. Perinatal and neonatal data were collected for descriptive analysis. Complications of neonatal intensive care therapy included late-onset necrotizing enterocolitis (NEC), multiple organ dysfunction syndrome (MODS), ventilator associated pneumonia (VAP), antibiotic-associated diarrhea (AAD), and late-onset sepsis (LOS). Results: Out of 2940 neonates admitted to the neonatal wards 403 fulfilled the inclusion criteria and comprised the study population. Median gestational age was 38 weeks and birth weight 3300 grams, median length of stay 10 days; 246 (61%) neonates needed ventilatory support and 334 (83%) received antibiotic treatment. None of the neonates developed NEC, MODS, VAP, or AAD. Sixteen (4.0%) neonates developed LOS. Blood cultures were all negative for LCR. Breast milk feeding was evident in 13% (2/16) of the neonates with LOS compared to 30% (121/387) in those without LOS (P = 0.055). Conclusions: Over an 11-year period use of a standardized prophylactic anti-infective regimen was safe and resulted in a very low incidence of predefined complications in critically ill term neonates.