Kuschel 2000.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inclusion criteria: infants less than 30 weeks' gestation at birth Exclusion criteria: babies who did not survive until reaching full enteral feeds, babies with congenital malformations that are associated with poor postnatal growth |
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Interventions | Intervention: 200 mL/kg/day enteral feeds Control: 150 mL/kg/day feeds Randomisation was done when baby was approaching 150 mL/kg per day feed volume. |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | Setting: Australia Study period: 1995 to 1996 Infants with < 1500 grams birth weight received human milk fortified with human milk fortifier or preterm formula. The fortification was continued until the infant reached 1800 to 2000 grams. If a minimum weight gain of 8 g/kg/day was not achieved, feed volume was increased beyond 150 mL/kg/day in the control group and caloric supplement was added in the intervention group. If infants in the intervention group developed feed intolerance, feed volume was decreased to the maximum tolerated volume. If feed volume was decreased, every effort was made to increase the volume back to 200 mL/kg/day. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Personal communication: (quote:) "computer‐generated random sequence" |
Allocation concealment (selection bias) | Low risk | Quote: "Opaque sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Clinicians and nursing staff were not blinded to the intervention". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Anthropometric measurements were performed by investigators unmasked to the infant’s volume allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All babies enrolled in the study were accounted for. |
Selective reporting (reporting bias) | Low risk | Personal communication (quote:) "all proposed outcomes reported" |
Other bias | Low risk | None |