Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was conducted according to a random computer‐determined allocation order considering gestational age" |
|
|
Comment: Most likely done |
Allocation concealment (selection bias) |
Unclear risk |
No clear information available for allocation concealment |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: "Blinding was possible because the nurses who administered L. reuteri to the infants were not involved in the daily care and the attending neonatal team was unaware of the randomization assignments" |
Blinding of outcome assessment (detection bias) |
Unclear risk |
It was not clear if the families of the participating neonates were aware of the treatment assignments |
Incomplete outcome data (attrition bias) |
Low risk |
About 18% attrition reported that was balanced in two groups |
Selective reporting (reporting bias) |
Low risk |
Authors seem to report all the relevant outcomes |
Other bias |
Low risk |
No other risk of bias was noted |