Maggio 2005.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Preterm infants (≤ 34 weeks' gestational age, ≤ 1750 g at birth) | |
| Interventions | Empirical use of partially hydrolysed whey‐based formula* (n = 10) Conventional preterm formula* (n = 11) |
|
| Outcomes | Growth rates from inclusion until hospital discharge Feed intolerance (no infants had enteral feeds interrupted) |
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| Notes | Division of Neonatology, Department of Paediatrics, Catholic University of the Sacred Heart, Rome, Italy Trial dates: 1998 to 2000 * Energy content of both formulas: 75 kcal/100 mL |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised schedule generated ‐ not specified how |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study and control formulas identical in colour and smell |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study and control formulas identical in colour 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 Humana (manufacturer of the trial formula) |