Szajewska 2004.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Preterm infants, body weight < 2500 g with ≥ 1 first‐degree relative with atopy | |
| Interventions | Extensively (n = 26) or partially hydrolysed whey‐casein preterm formula* (n = 32) Standard preterm formula* (n = 32) |
|
| Outcomes | Allergic disease in infancy Feed intolerance |
|
| Notes | Primary aim: to assess effects on allergy and atopic disease In‐hospital feed tolerance, growth, and adverse outcomes not reported. We contacted corresponding author in December 2016 to seek these data * Energy content of both formulas: 80 kcal/100 mL 33% "dropout" before assessment at 4 to 5 months post term |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised schedule generated ‐ unspecified how |
| Allocation concealment (selection bias) | Low risk | Sealed numbered envelopes ‐ not stated whether opaque, but codes concealed from investigators until trial completed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Double‐blind" but study and control formulas not identical in texture and smell |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Double‐blind" but study and control formulas not identical in texture and smell |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all participants |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | Unclear risk | Funded by Ovita Nutricia Research Foundation |
n: number of infants. RCT: randomised controlled trial.