| Study characteristics |
| Methods |
RCT |
| Participants |
145 VLBW infants |
| Interventions |
Probiotics (N = 72): "Lactobacillus bifidus" (likely Bifidobactrium bifidum), Streptococcus thermophilus, and B. infantis added to expressed breast milk or formula enteral feeds daily until 36 weeks' postmenstrual age
Control (N = 73): unsupplemented milk feeds |
| Outcomes |
|
| Notes |
Israel (2001 to 2004)
Funding: Solgar, Wyeth (manufacturer of intervention) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Unsupplemented milk feeds‐ not placebo‐controlled |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete |
| Selective reporting (reporting bias) |
Unclear risk |
Data published in an abstract form on two previous occasions at the Society of Pediatrics Research (SPR 2003, 2005) with different inclusion criteria and clinical outcomes |
