Random sequence generation (selection bias) |
Low risk |
Coding to group 1 and 2 was done by a faculty of another department not related to this study. First case was selected to 1 group by lottery method and subsequent group was continued accordingly |
Allocation concealment (selection bias) |
Low risk |
Participants and investigators did not know group allocation |
Blinding of participants and personnel (performance bias) |
Low risk |
Probiotics were added to breast milk by registrar or assistant registrar of the corresponding unit before feeding |
Blinding of outcome assessment (detection bias) |
Low risk |
Participants and investigators did not know group allocation |
Incomplete outcome data (attrition bias) |
Low risk |
15% attrition. Reasons for loss to follow up reported. |
Selective reporting (reporting bias) |
Low risk |
All expected outcomes were reported |
Other bias |
Low risk |
No concerns for other risk of bias |