Comparison of probiotics and placebo in preventing necrotizing enterocolitis in preterm babies.

Abstract

Objective: To compare the probiotics with placebo in preventing the necrotizing enterocolitis (NEC) in preterm newborns. Study Design: Randomized Controlled Trial. Setting: Department of Pediatrics Unit-1, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Period: May 2022 to April 2023. Material & Methods: A total of 92 pre-term neonates with gestational age between 28-32 weeks gestation were included. Patients were randomly assigned to either probiotics or placebo groups (46 in each group). In probiotics group, probiotics named Bifidobacteria (hiflora/gutcare one sachet daily) were given for 5 days while in placebo group, neonates were given placebo for 5 days. All neonates were observed for feeding intolerance, abdominal distension, grossly bloody stools (naked eye blood in stool) and change in colour of skin of abdomen (erythema). Patients having three or more of these features in first 7 days of life were labeled as having NEC. Results: In a total of 92 newborns, maternal age ranged between 18 to 40 years with mean age of 29.30±5.27 years. The mean gestational age was 30.88±2.08 weeks while the mean weight was 2.06±0.71 kg. The NEC was found in 3 (6.52%) neonates in probiotics groups versus 11 (23.9%) in placebo group (p=0.020). In the probiotics group, NEC was found to have significant association with gestational age between 31-32 weeks (p=0.012), spontaneous vaginal delivery (p=0.028) and maternal educational status as educated (p=0.006). In the placebo group, NEC had significant association with birth weight between 1-1.5 kg (p=0.007). Conclusion: This study concluded that probiotics are better in preventing NEC in preterm neonates than placebo.