Serce 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 208 very preterm or VLBW infants | |
Interventions | Probiotics (N = 104): Saccharomyces boulardii in human milk or formula once daily until discharge from hospital Control (N = 104): unsupplemented milk feeds | |
Outcomes |
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Notes | Turkey (2010 to 2011) Funding: Biocodex supplied the intervention |
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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 | Opaque, sequentially‐numbered, 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 | Complete |
Selective reporting (reporting bias) | Low risk | Unlikely |