Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of probiotics on growth and development in premature infants have been investigated poorly. Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast. Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce feeding intolerance, and had no adverse effects.
The objective of this study is to evaluate if feeding supplemented with S. boulardii can improve growth and clinical outcomes in preterm and low birth weight infants. A prospective, randomized case-controlled trial was conducted in infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g. The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group. The primary outcomes were short term growth parameters including weight gain, linear growth, head and chest circumference, and secondary outcomes were clinical outcomes, feeding intolerance and complications. A total of 125 infants were enrolled in the study, 63 in the treatment and 62 in the control group. S. boulardii was administered for the first time at 2.63 days after birth (1 day to 6 days, 46 within 3 days, only 5 between 4 and 6 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
125
50 mg/kg twice daily
he control group (group C) did not receive S. boulardii (nor other probiotics)
weight
weight gain (g/d)
Time frame: The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.
days of parenteral nutrition to full enteral nutrition
count the days of parenteral nutrition to full enteral nutrition
Time frame: The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.
maximal enteral feed
measure maximal enteral feed (ml/day)
Time frame: The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.
fasting time
count fasting time (days)
Time frame: The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.
duration of hospitalisation
count the duration of hospitalisation (days)
Time frame: The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.
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