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. 2021 Aug 24;2021(8):CD001241. doi: 10.1002/14651858.CD001241.pub8

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
  • NEC

  • Time to regain birth weight

  • Time to achieve full enteral feeds

  • Time to hospital discharge

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