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

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
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
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)