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. 2020 Dec 27;2020(12):CD013542. doi: 10.1002/14651858.CD013542.pub2

Bora 2017.

Study characteristics
Methods Randomised controlled trial
Participants 107 "stable" VLBW infants (1000–1500 g birth weight), irrespective of gestational age at birth
Setting: Department of Paediatrics, Assam Medical College, Assam, India
Interventions Intervention (n = 52): full enteral feeds (80 mL/kg/day) with expressed breast milk or donor breast milk
Control (n = 55): minimal enteral feeds (20 mL/kg/day) supplemented with intravenous 10% dextrose
Feed volumes increased by 20 mL/kg/day as tolerated
Outcomes
  1. Feed intolerance (vomiting > 3 times/24 hours, or bile or blood‐stained vomit, or abdominal girth increase > 2 cm, or prefeed gastric aspirate > 50% previous feed volume, or altered aspirate, or abdominal wall erythema, or gross blood in stools)

  2. Necrotising enterocolitis (Bell's criteria)

  3. Days to regain birth weight

Notes Human milk was enriched with a multi‐nutrient fortifier when infants reached an intake volume of volume of 100 mL/kg/day.
The intervention group contained more infants born to mothers with pregnancy induced hypertension (51%) than the control group (31%).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated.
Allocation concealment (selection bias) Low risk Sealed opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not masked.
Blinding of outcome assessment (detection bias)
All outcomes High risk Not masked.
Incomplete outcome data (attrition bias)
All outcomes Low risk Near‐complete (103/107 participants).
Selective reporting (reporting bias) Unclear risk No protocol to compare. All outcomes in methods section reported.
Other bias Unclear risk No funding source reported.