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. 2022 Jan 20;2022(1):CD001970. doi: 10.1002/14651858.CD001970.pub6

Davey 1994.

Study characteristics
Methods Randomised controlled trial
Participants Preterm infants with birth weight < 2000 g who were clinically stable and who had an umbilical artery catheter in place
Infants were excluded if they had a lethal condition or had received a double‐volume exchange transfusion
Setting: Division of Neonatology, Department of Pediatrics, University of Rochester Medical Center, USA (study dates not stated)
Interventions Delayed introduction of enteral feeds (median 5 days; 31 infants) versus earlier introduction (median 2 days; 31 infants)
Infants received either breast milk or diluted formula (no subgroup data available)
Outcomes
  • NEC (Bell stage 2/3)

  • Mortality

  • Days to full enteral feeding

  • Duration of hospital stay

Notes A trial inclusion criterion for birth weight was < 2000 g (mean birth weight 1100 g; > 80% of infants were VLBW or very preterm)
Infants in the delayed introduction group commenced enteral feeds when the umbilical artery catheter had been removed for 24 hours and the infant was clinically stable and infants in the earlier introduction group commenced feeds with the umbilical artery catheter in situ
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation method not reported
Allocation concealment (selection bias) Low risk Sealed opaque 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 Complete cohort assessed
Selective reporting (reporting bias) Low risk Unlikely
Other bias Low risk No evidence baseline imbalance