Location of study
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Athens, Greece
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University of Bari, Policinico, Italy
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Gainesville, Florida, USA
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Alexandra Regional Hospital, Greece
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Participants - inclusion criteria
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28 - 32 weeks gestation
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3- 5 days old, appropriate for gestational age, preterm infants with normal agpar scores
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Premature infants, <2000g at birth, less than 72 hours old (>24 old to <72 hours old)
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27 to 37 weeks gestation, in stable state
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Number of study participants
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Study group=51 , Placebo = 36
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Study group = 10 , Placebo = 10
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Study group = 15, Placebo = 15
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Study group = 41, Placebo = 34
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Probiotic bacteria used
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Saccharomyces Bourlardii
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Lactobacillus Reuteri ATCC 55730
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Lactobacillus acidophilus
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Bifidobacteriumlactis
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Dose of probiotic
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109cfu at 50mg/kg every 12 hours
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1 X 108cfu/day
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9 X 106cfu/ml formula
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2 X 107cfu/g milk powder
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Placebo
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Maltodextrin
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Indistinguishable placebo
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Conventional preterm formula
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Conventional preterm formula
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Dose of placebo
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50 mg /kg / 12 hours
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Not reported
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Treatment initiation
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1st week of life as soon as enteral feed was tolerated
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At 3–5 days of life
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1st 72 hours of life
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1st 2 days of life
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Treatment duration
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30 days
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30 days
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Not specified
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30 days
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Reported Outcomes
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Growth parameters
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Weight gain
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Weight gain
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Weight gain
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Weight gain, Linear growth, Head circumference
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Timing and duration of measurement of growth parameters
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Measured daily for 30 days
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Measured daily for 30 days
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Measured daily, duration not specified
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Weight gain: measured daily, Lineargrowth (measured weekly), Head circumference (measured weekly)
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Feed tolerance
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Number of days to full enteral feed, Maximal enteral feed, vomiting
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Number of days to full enteral feed, Maximal enteral feed, vomiting
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Maximal enteral feed
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Number of days to full enteral feed, Maximal enteral feed
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Stool characteristics
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Stooling frequency
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Complications
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NEC, Sepsis
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Mortality / death
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NEC, Sepsis
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Intestinal permeability
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Changes in Intestinal permeability
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Changes in Intestinal permeability
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Changes in gastrointestinal microflora |
cfu of bifidobacteria, lactobacillus, pathogens |
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cfu of bifidobacteria |