BACKGROUND:Necrotizing enterocolitis (NEC) is the most serious gastrointestinal problem in very low birth weight preterm infants. Multiple risk factors activate the inflammatory cascade leading to high expressions of pro-inflammatory mediators causing bowel injury in NEC. The anti-inflammatory effect of probiotics is due to the inhibition and reduction of inflammatory signal in intestinal epithelium. OBJECTIVE: To evaluate the efficacy of probiotics supplementation in the prevention of NEC among very low birth weight preterm infants. STUDY DESIGN: A prospective randomized controlled trial. MATERIAL AND METHOD:All preterm infants with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1,500 grams admitted in neonatal care unit, Queen Sirikit National Institute of Child Health during June 1st, 2012 and January 31th, 2013 were enrolled in this study. They were randomized into two groups, study and control group. Infants in the study group were fed Infloran (Lactobacillus acidophilus 1 x 10(9) and Bifidobacterium bifidum 1 x 10(9) organisms) dose 125 mg/kg/dose twice a day with breast milk or premature formula from the start of feeding until 6 weeks or discharge. Infants in the control group were fed with either breast milk or premature formula alone. The primary outcome was NEC stage ≥ 2. RESULTS:Sixty infants completed the study, 31 infants in the study group and 29 infants in the control group. The baseline characteristic data of infants were similar except for more males in the present study group. Incidence of NEC stage ≥ 2 were similar in both the groups, 3.2 vs. 3.4% (p = 0.74). There were no deaths during the study period. Days to reach full feeding, 150 ml/kg/day, were no differences between the two groups, 12.03 ± 5.49 days vs. 13.76 ± 8.25 days (p = 0.31). No adverse effects such as sepsis, flatulence or diarrhea were noted. CONCLUSION: In this study, there was no difference in incidence of NEC stage ≥ 2 between the two groups. No adverse effects of probiotics supplementation were observed.
RCT Entities:
BACKGROUND:Necrotizing enterocolitis (NEC) is the most serious gastrointestinal problem in very low birth weight preterm infants. Multiple risk factors activate the inflammatory cascade leading to high expressions of pro-inflammatory mediators causing bowel injury in NEC. The anti-inflammatory effect of probiotics is due to the inhibition and reduction of inflammatory signal in intestinal epithelium. OBJECTIVE: To evaluate the efficacy of probiotics supplementation in the prevention of NEC among very low birth weight preterm infants. STUDY DESIGN: A prospective randomized controlled trial. MATERIAL AND METHOD: All preterm infants with gestational age less than or equal to 34 weeks and birth weight less than or equal to 1,500 grams admitted in neonatal care unit, Queen Sirikit National Institute of Child Health during June 1st, 2012 and January 31th, 2013 were enrolled in this study. They were randomized into two groups, study and control group. Infants in the study group were fed Infloran (Lactobacillus acidophilus 1 x 10(9) and Bifidobacterium bifidum 1 x 10(9) organisms) dose 125 mg/kg/dose twice a day with breast milk or premature formula from the start of feeding until 6 weeks or discharge. Infants in the control group were fed with either breast milk or premature formula alone. The primary outcome was NEC stage ≥ 2. RESULTS: Sixty infants completed the study, 31 infants in the study group and 29 infants in the control group. The baseline characteristic data of infants were similar except for more males in the present study group. Incidence of NEC stage ≥ 2 were similar in both the groups, 3.2 vs. 3.4% (p = 0.74). There were no deaths during the study period. Days to reach full feeding, 150 ml/kg/day, were no differences between the two groups, 12.03 ± 5.49 days vs. 13.76 ± 8.25 days (p = 0.31). No adverse effects such as sepsis, flatulence or diarrhea were noted. CONCLUSION: In this study, there was no difference in incidence of NEC stage ≥ 2 between the two groups. No adverse effects of probiotics supplementation were observed.
Authors: Rebecca L Morgan; Geoffrey A Preidis; Purna C Kashyap; Adam V Weizman; Behnam Sadeghirad Journal: Gastroenterology Date: 2020-06-24 Impact factor: 22.682