| Study characteristics |
| Methods |
RCT |
| Participants |
485 VLBW infants |
| Interventions |
Probiotics (N = 238): Lactoacillus casei subspecies rhamnosus with human milk or formula until 4 (VLBW) or 6 (ELBW) weeks plus bovine lactoferrin (100 mg/day)
Control (N = 247): bovine lactoferrin alone
(All doses including placebo were diluted in prepared milk so as to maintain masking) |
| Outcomes |
|
| Notes |
Italy (11 centres: 2007 to 2008)
Funding: Dicofarm SpA (manufacturer of intervention) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated |
| Allocation concealment (selection bias) |
Low risk |
Pharmacy allocation (remote) |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Masked |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete |
| Selective reporting (reporting bias) |
Unclear risk |
Data for invasive infection in complete cohort not reported in primary publication (available to derive from later publications) |
