Picaud 2001.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Preterm newborns with birth weight < 1500 g and aged < 15 days when enteral feeds commenced | |
| Interventions | Empirical use of partially hydrolysed formula* (n = 9) Standard preterm formula* (n = 7) Until 40 weeks' postmenstrual age |
|
| Outcomes | Rate of weight gain during initial hospital admission Nitrogen balance studies |
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| Notes | Edouard Herriot Hospital, Claude Bernard University, Lyon, France Trial date: late 1990s * Energy content of both formulas: 80 kcal/100 mL, but nitrogen content 10% higher in standard preterm formula |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Sealed envelopes ‐ unclear whether opaque |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Investigators unaware of formula; unclear if carers or parents aware |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Investigators unaware of formula; unclear if carers or parents aware |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants assessed for primary outcomes |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | Unclear risk | Funder: Nestle (manufacturer of the trial formula) |