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. 2020 Oct 15;2020(10):CD005496. doi: 10.1002/14651858.CD005496.pub5

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
Outcomes
  • NEC

  • Death

  • Duration of hospital stay

Notes India (2012 to 2013)
Funding: not stated
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All outcomes Low risk Near‐complete (3 infants in each group withdrawn)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