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 |
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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) |
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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. |