Shashidhar 2017.
Study characteristics | ||
Methods | RCT | |
Participants | 104 VLBW infants | |
Interventions | Probiotics (N = 52): Lactobacillus acidophilus, L. rhamnosus, Bifidobacterium longum and Saccharomyces boulardii (Darolac) once daily in human milk until discharge from hospital Control (N = 52): unsupplemented milk feeds |
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Outcomes |
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Notes | India (2012 to 2013) Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered, opaque. sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unsupplemented milk feeds‐ not placebo‐controlled |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Near‐complete (3 infants in each group withdrawn) |
Selective reporting (reporting bias) | Low risk | Unlikely |