Methods
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A randomized, placebo‐controlled trial conducted in India |
Participants
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Inclusion criteria:
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(1)
Neonates born at 27–33 weeks gestation in our hospital
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(2)
aged <96 h of life
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(3)
who were likely to either remain admitted in hospital or reside within 30 km of the hospital for the next 28 days
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(4)
who were tolerating at least 15 ml/kg/day of milk feeds
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Exclusion criteria:
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Interventions
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Intervention group: Probiotic Lactobacillus acidophilus (662.5 million), Lactobacillus rhamnosus (362.5 million), Bifidobacterium longum (87.5 million), and Saccharomyces boulardii (137.5 million) |
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Four groups |
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A.
High‐dose long course 1010 cells 12 hourly for 21 days
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B.
High‐dose short course 1010 cells 12 hourly for days 1–14; followed by placebo from days 15–21
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C.
Low‐dose long course 109 cells 12 hourly for 21 days
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D.
Control group: Placebo for 21 days
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Outcomes
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NEC, mortality and sepsis |
Notes
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We combined all the probiotics groups (group A + B + C) to avoid the double counting of the placebo. |