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. 2020 Sep 23;2020(9):CD000433. doi: 10.1002/14651858.CD000433.pub3

Putet 1987.

Study characteristics
Methods Parallel randomised controlled trial, single centre
Participants Inclusion criteria: VLBW boys of appropriate weight for gestational age and no infant had medical problems at the time of the study
Exclusion criteria: not stated
Setting: not stated
Timing: not stated
Interventions Cow's milk casein hydrolysate (1 g per 100 mL) added to pooled human milk (8 infants) versus unsupplemented pooled human milk (8 infants). Duration of intervention was not clear.
Outcomes Primary: not specified as primary and secondary outcomes, but short‐term growth parameters were assessed, including weight, length, head circumference. Total serum protein, BUN, acid‐base status, free amino acids, nitrogen retention, bicarbonate level, oxygen consumption, and energy expenditures were also assessed.
Notes Conflicts of interest: no details
Source of funding: supported by a grant from University Claude Bernard (Lyon) and by an INSERM Contract (PRC 123.0228)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Unclear risk No details
Blinding (performance bias and detection bias)
All outcomes Unclear risk No details
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No details
Selective reporting (reporting bias) Low risk The protocol was not available, but it appeared that all pre‐specified outcomes were measured and reported.
Other bias Low risk No other apparent sources of bias related to the study design noted. No extreme baseline imbalances observed.