Raban 2014b.
Study characteristics | ||
Methods | Randomised controlled trial (2 × 2 factorial design with Raban 2014a) | |
Participants | ELBW infants Setting: Groote Schuur Hospital, Cape Town, South Africa (2011 to 2013) |
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Interventions | Feed advancement (from 24 mL/kg/d on day 1) in daily increments of 24 mL/kg (n = 52) vs 36 mL/kg (n = 50) until enteral feeds of 200 mL/kg/d were attained | |
Outcomes |
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Notes | Factorial design also randomised to commencing feeds on day 1 (24 mL/kg) or day 2 (12 mL/kg). Infants received maternal‐expressed breast milk or donor breast milk. Trial registration: ISRCTN96923718 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up for primary outcomes |
Selective reporting (reporting bias) | Low risk | Unlikely |
Other bias | Low risk | No evidence of baseline imbalance |