Abstract
Background: Nosocomial infections are frequent in preterm infants.
Objective: To investigate whether Bifidobacterium lactis (B. lactis; C. Hansen, Danmark) reduces the incidence of nosocomial infections.
Methods: In a double-blind placebo controlled trial 128 preterm infants less than 30 weeks of gestation were stratified according to their gestational age (23–26 and 27–29 weeks) and randomly assigned to have their milk feedings (human milk or preterm formula) supplemented with B. lactis (6 × 109 cfu/kg/day) or placebo for the first six weeks of life. Early enteral nutrition following a standardized feeding protocol was performed. Primary outcome was the incidence density of nosocomial infections from day 7 after initiation of milk feedings until the 42nd day of life (number of nosocomial infections/total number of patient days). In case of suspected nosocomial infection both aerob and anaerob blood cultures were performed. Nosocomial infections were defined as periods of elevated CRP (C-reactive protein; >10 mg/dl). The sample size was calculated to proof a reduction in the incidence density of nosocomial infections of at least 25% (á=0.05, á =0.80). An adaptive interim analysis was scheduled to be performed after at least 50 infants in each group who were treated according to protocol. Data are presented as median and range where appropriate.
Results: The trial was stopped at the interim analysis for futility. There was no significant difference between the two groups with regard to clinical characteristics, patient days, total number of observed nosocomial infections and the incidence density of nosocomial infections (p = 0.9, Chi2–test). B. lactis has not been detected in any of the blood cultures.
Conclusion: In the setting of the study treatment with B. lactis at a dosage of 6 x 109 cfu/kg/day appeared to be safe, however, there was no reduction in the incidence density of nosocomial infections.
Disclosure: The study was supported by Nestlé, Germany.
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Mihatsch, W., Vossbeck, S., Franz, A. et al. 184 Effect of Bifidobacterium Lactis on The Incidence of Nosocomial Infections in Preterm Infants. Pediatr Res 56, 495 (2004). https://doi.org/10.1203/00006450-200409000-00207
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DOI: https://doi.org/10.1203/00006450-200409000-00207