The Effect of Probiotics on Health Outcome in Preterm Infants: A Randomized Clinical Trial

Background: The relatively high prevalence of preterm infants (10%) often necessitates long hospitalizations and stays in intensive care units. In this regard, probiotics have been suggested to reduce associated risks. Objectives: This study aimed to compare the effect of two types of probiotics in Iran with a placebo on reducing morbidity and improving health outcomes in preterm infants. Methods: In this randomized controlled trial (RCT), 98 preterm infants were admitted with a gestational age of ≤ 37 weeks and weighing 1000 - 2000 g. Neonates were randomly divided into two intervention groups and one placebo group. Each neonate received 5 drops of the assigned treatment daily. The studied variables included demographic characteristics of the mother and neonate, feeding start time, time to reach full enteral feeding, the incidence of necrotizing enterocolitis (NEC), jaundice (icterus), duration of hospitalization, and daily weight gain. Results: The mean days for oxygen therapy and phototherapy in the group receiving probiotics were significantly reduced compared to the placebo group. The highest weight gain was observed in the group receiving Pedilact, which was also more remarkable than the Reuteflor group. However, the incidence of jaundice, NEC, and mortality, time to reach full enteral feeding, and mean days of hospitalization in the study groups were not statistically significant (significance level α = 0.05). Conclusions: Results showed that probiotics can be effective in improving health outcomes such as weight gain, enhancing the intestinal function of hospitalized preterm infants, and reducing the required time for oxygen therapy and phototherapy in preterm infants.