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. 2019 Jul 24;2019(7):CD012412. doi: 10.1002/14651858.CD012412.pub3

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
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.