Protective Effect of Dual-Strain Probiotics in Preterm Infants: A Multi-Center Time Series Analysis.

OBJECTIVE: To determine the effect of dual-strain probiotics on the development of necrotizing enterocolitis (NEC), mortality and nosocomial bloodstream infections (BSI) in preterm infants in German neonatal intensive care units (NICUs).

DESIGN: A multi-center interrupted time series analysis.

SETTING: 44 German NICUs with routine use of dual-strain probiotics on neonatal ward level.

PATIENTS: Preterm infants documented by NEO-KISS, the German surveillance system for nosocomial infections in preterm infants with birth weights below 1,500 g, between 2004 and 2014.

INTERVENTION: Routine use of dual-strain probiotics containing Lactobacillus acidophilus and Bifidobacterium spp. (Infloran) on the neonatal ward level.

MAIN OUTCOME MEASURES: Incidences of NEC, overall mortality, mortality following NEC and nosocomial BSI.

RESULTS: Data from 10,890 preterm infants in 44 neonatal wards was included in this study. Incidences of NEC and BSI were 2.5% (n = 274) and 15.0%, (n = 1631), respectively. Mortality rate was 6.1% (n = 665). The use of dual-strain probiotics significantly reduced the risk of NEC (HR = 0.48; 95% CI = 0.38-0.62), overall mortality (HR = 0.60, 95% CI = 0.44-0.83), mortality after NEC (HR = 0.51, 95% CI = 0.26-0.999) and nosocomial BSI (HR = 0.89, 95% CI = 0.81-0.98). These effects were even more pronounced in the subgroup analysis of preterm infants with birth weights below 1,000 g.

CONCLUSION: In order to reduce NEC and mortality in preterm infants, it is advisable to add routine prophylaxis with dual-strain probiotics to clinical practice in neonatal wards.