Location of study
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Milan, Italy
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University of Bari, Policinico, Italy
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Athens, Greece
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Ulm University, Germany
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Participants - entry criteria
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<32 weeks gestation
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Healthy preterm newborns
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≤ 36 weeks gestation
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< 1500 g birth weight
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Number of study participants
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Study group = 15, Placebo = 15
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Study group = 10 , Placebo = 10
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Study group = 36, Placebo = 20
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Study group = 10, Placebo = 10
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Prebiotic used
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GOS 90%, FOS 10%
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scGOS, lcFOS at ratio 9:1
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FOS
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GOS, FOS
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Dose of prebiotic
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1g/dl
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0.8 g/dl
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0.4g/100ml
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1g/dl
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Placebo
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Maltodextrin
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Maltodextrin
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Maltodextrin
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Maltodextrin
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Dose of placebo
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1 g/dl
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0.8 g/dl
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0.4 g
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1.8 / 90 ml
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Treatment initiation
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When enteral feed ≥ 80 mls /kg/day was tolerated
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Not clear
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Exclusively formula fed at start of study
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At full enteral feed at start of study
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Treatment duration
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28 days
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15 days
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14 days
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15 days
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Reported Outcomes
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|
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Growth parameters
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Weight gain, linear growth
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Weight gain, linear growth, head growth
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Weight gain, linear growth, head growth
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Weight gain
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Timing and duration of measurement of growth parameters
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Measured on days 1, 7, 14, 28
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Measured before start of study, days 3, 5, 15
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Measured on days 1, 7, 14
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Weight gain: reported as “Average weight gain during study.”
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Feed tolerance
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Number of days to full enteral feed, maximal enteral feed
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Number of days to full enteral feed, maximal enteral feed
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Number of days to full 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, consistency
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Stooling frequency, consistency
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Stool viscosity, Stooling frequency, consistency
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Changes in gastrointestinal microflora |
cfu bifidobacteria |
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cfu bifidobacteria, pathogens |
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