Infant, Premature, Diseases
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGS. boulardii
50 mg/kg twice daily
DRUGPlacebo
he control group (group C) did not receive S. boulardii (nor other probiotics)
Sponsors
Lingfen Xu, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* The inclusion criteria were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight | 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. | weight gain (g/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of hospitalisation | 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. | count the duration of hospitalisation (days) |
| maximal enteral feed | 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. | measure maximal enteral feed (ml/day) |
| days of parenteral nutrition to full enteral nutrition | 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. | count the days of parenteral nutrition to full enteral nutrition |
| fasting time | 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. | count fasting time (days) |
Other
| Measure | Time frame | Description |
|---|---|---|
| head circumference | 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. | head circumference growth (cm/week) |
| chest circumference | 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. | chest circumference growth (cm/week). |
| linear | 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. | linear growth (cm/week) |
Outcome results
None listed