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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study group | Active Comparator | The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group. |
|
| The control group | Placebo Comparator | A prospective, Placebo Comparator,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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S. boulardii | Drug | 50 mg/kg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight gain (g/d) | 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 | Description | Time Frame |
|---|---|---|
| days of parenteral nutrition to full enteral nutrition | count the 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. |
| maximal enteral feed |
| Measure | Description | Time Frame |
|---|---|---|
| linear | linear growth (cm/week) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Drug | he control group (group C) did not receive S. boulardii (nor other probiotics) |
|
|
measure maximal enteral feed (ml/day) |
| 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) | 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) | 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)
| 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 | chest circumference growth (cm/week). | 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. |
| D019602 |
| Food and Beverages |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |