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

Riezzo 2001.

Study characteristics
Methods RCT
Participants Preterm infants (n = 36)
Interventions Partially hydrolysed casein preterm formula* (n = 18)
Standard (whey‐casein) formula* (n = 18)
Outcomes Proportion of infants who had > 1 episode of regurgitation or vomiting per day
Notes Department of Pediatrics, Neonatology Section, University of Bari, Bari, Italy
Trial date: 2000
Energy content of hydrolysed formula (80 kcal/100 mL) higher than control standard term formula (68 kcal/100 mL). Because trial did not report growth rates (the reason for specifying similar energy levels in comparison formulas), we made a consensus decision to include the trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear evidence provided ‐ stated only that infants were randomly assigned
Allocation concealment (selection bias) Unclear risk Unclear evidence provided ‐ stated only that infants were randomly assigned
Blinding of participants and personnel (performance bias)
All outcomes High risk Unblinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Unblinded
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: not stated