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. 2021 Mar 12;2021(3):CD012413. doi: 10.1002/14651858.CD012413.pub3

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
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.
Outcomes Primary outcome
  • Growth measures such as weight, length, head circumference, arm area, arm muscle, arm fat area at 35 weeks' PMA, and mean weight gain in g/kg/day


Secondary outcomes
  • PMA and weight at which fortification or preterm formula is ceased

  • PMA when reaching full sucking feeds

  • PMA and weight at the time of discharge

  • Growth measures such as weight, length and head circumference at 12 months' corrected age, developmental assessment using Griffiths Mental Development Scales at 12 months' corrected age

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.
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