Rayyis 1999.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | VLBW infants of gestational age < 34 weeks at birth Setting: Neonatal Unit, Department of Pediatrics, University of Alabama, Birmingham, Alabama, USA (dates not stated) |
|
Interventions | Feed advancement at 15 mL/kg/d (n = 98) vs 35 mL/kg/d (n = 87) | |
Outcomes |
|
|
Notes | Infants for whom full or partial feeding with expressed breast milk was planned were not eligible to participate. Feeds were ceased if: residual gastric contents > 30% of previous feed volume, abdominal distension or tenderness, or bloody stools (including occult blood). |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes |
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 | 7 protocol violations occurred after enrolment, but all infants were included in the final data analysis. |
Selective reporting (reporting bias) | Low risk | Unlikely |
Other bias | Low risk | No evidence of baseline imbalance |