Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was conducted according to a random computer‐determined allocation order considering birth weight" |
Allocation concealment (selection bias) |
Low risk |
Quote: "Blinding was possible because the nursing staff who administered S. boulardii to the infants was not involved in the daily care and the attending neonatal team was unaware of the randomization assignments" |
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Comment: Less likely that randomization sequence was revealed |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: "Blinding was possible because the nursing staff who administered S. boulardii to the infants was not involved in the daily care and the attending neonatal team was unaware of the randomization assignments" |
Blinding of outcome assessment (detection bias) |
Low risk |
Quote: "Blinding was possible because the nursing staff who administered S. boulardii to the infants was not involved in the daily care and the attending neonatal team was unaware of the randomization assignments" |
Incomplete outcome data (attrition bias) |
High risk |
Quote: "25 (20%) patients were considered dropouts" |
Selective reporting (reporting bias) |
Low risk |
Authors seem to report all the outcomes irrespective of their statistical significance |
Other bias |
Low risk |
No other risk of bias was noted |