The Effect of Probiotics on Late-Onset Sepsis in Very Preterm Infants: A Randomized Clinical Trial


Background Late onset sepsis is a frequent complication of prematurity, associated with increased mortality and morbidity. Probiotics may prevent late onset sepsis in premature infants. The aim of this study was to determine prophylactic effect of oral probiotics in prevention of late onset sepsis of very preterm infants. Materials and Methods This study was a randomized, double blinded, placebo controlled trial. Eighty preterm infants born at < 32 weeks gestation weighing 1,000- 1,500 gr randomly assigned in intervention and control groups. From soon after the start of feeds, intervention group received Pedilact drop, which was a probiotic and control group received distilled water (DW) as placebo, 1 drop per kg of body weight every 12 hours, made by Zist-Takhmir, Iran Company. After data collection incidence of late onset sepsis, mortality, time to establish full enteral feeding and duration of hospitalization were compared between two groups. Results Cause of hospitalization in all patients was respiratory distress and prematurity. The incidence of late sepsis and death in the intervention group was lower than the control group, which was significant. The mean time to establish full enteral feeding in the probiotic group was lower than the control group. No case of necrotizing enterocolitis was observed. There was no difference in terms of days of hospitalization among two groups (P>0.05). Conclusion According to the results, usage of prophylactic probiotics can reduce the incidence of late onset sepsis and its mortality. By consuming probiotics preterm infants could reach the full enteral feeding in a shorter period of time, but the duration of hospitalization not reduced.