Random sequence generation (selection bias) |
Low risk |
Quote: " Study participants were randomly assigned to probiotic or placebo by the use of a computer‐generated balanced block randomization scheme" |
Allocation concealment (selection bias) |
Low risk |
Quote: "Treatment assignment was performed by using sealed, sequentially numbered, opaque envelopes, color‐coded for strata, available in each NICU pharmacy" |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: "Infants were administered probiotic or placebo regardless of whether enteric feeds were started" |
Blinding of outcome assessment (detection bias) |
Low risk |
The authors do not report clearly if the outcome assessment was blinded, however in the setting of adequate allocation concealment and blinding of interventions it is less likely the outcome assessors knew the intervention vs placebo group |
Incomplete outcome data (attrition bias) |
Low risk |
Quote: "The study was terminated before the completion of the targeted sample because of a substantial drop in patient recruitment among participating institutions as well as funding restrictions that limited our ability to recruit the required additional subjects" |
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 |