Efficacy of Probiotics in Preterm Neonates in the Prevention of Necrotising Enterocolitis: A Randomised Controlled Tria

Abstract

Introduction: The most frequent and dangerous gastrointestinal emergency in newborns is Necrotising Enterocolitis (NEC). A novel and promising strategy for preventing NEC is enterally given probiotics. Aim: To evaluate the efficacy of probiotics in preterm neonates in the prevention of NEC and to assess the time of achievement of full feeds and duration of Intensive Care Unit (ICU) stay. Materials and Methods: The present study was a parallel design single-centre randomised controlled trial, conducted in Neonatal Intensive Care Unit (NICU), Department of Paediatrics, Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India, from November 2018 to April 2020. Total of 130 newborns were included after inclusion and exclusion criteria and were randomised into two groups: that is probiotic (group I, n=61) and non probiotic (group II, n=69) groups. The probiotic group was given probiotics with breastmilk and non probiotic group were given only breastmilk. Probiotic (Bifidobacterium breve M16V) 0.5 g was mixed with breastmilk and given twice daily till full feeds were reached. All neonates were followed-up on daily basis for the appearance of features of NEC. Other parameters like time of achievement of full feeds and duration of ICU stay were compared between the two groups. Descriptive and inferential statistical analysis was carried out in the present study. Results: Out of total sample, majority of babies belonged to the gestational age group of 30-33 weeks i.e., 30 (49.2%) in group I and 30 (43.5%) in group II. There were 29 (47.5%) females and 32 (52.5%) males in group I and, 32 (46.4%) females and 37 (53.6%) males in group II. There was a significant reduction of incidence of NEC (p-value=0.024) and earlier achievement of full feeds in the probiotic group (p-value=0.003) when compared to non probiotic group. The mean duration of ICU stay compared between the two groups was not statistically significant (p-value=0.366). Conclusion: Supplementation of probiotics to the preterm Low Birth Weight (LBW) babies helps in the reduction of incidence of NEC and also helps in earlier achievement of full feeds.