SIFT 2016.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Very preterm or VLBW infants | |
Interventions | Feeds advancement at 18 mL/kg/d (n = 1404) vs 30 mL/kg/d (n = 1400) (June 2013 to June 2015) | |
Outcomes |
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Notes | See: Declarations of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Computer‐based random allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked (radiologists may have been masked) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | > 99% outcome data for in‐hospital outcomes > 87% outcome data for neurodevelopmental outcomes at 18 to 24 months |
Selective reporting (reporting bias) | Low risk | Adhered to protocol |
Other bias | Low risk | No evidence of baseline imbalance |
ELBW: extremely low birth weight; n: number of infants; NEC: necrotising enterocolitis; VLBW: very low birth weight