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

Nangia 2019.

Study characteristics
Methods Randomised controlled trial
Participants 180 "stable" VLBW infants (1000–1499 g birth weight), of gestational age 28–34 weeks at birth
Setting: Department of Neonatology, Lady Hardinge Medical College, New Delhi, India
Interventions Intervention (n = 91): full enteral feeds (80 mL/kg/day) with expressed breast milk or preterm formula
Control (n = 89): minimal enteral feeds (20 mL/kg/day) supplemented with intravenous 10% dextrose
Feed volumes advanced by 20 mL/kg/day for 2 days, then 30 mL/kg/day
Outcomes
  1. Days to achieve full feeds (150 mL/kg/day)

  2. Feed intolerance

  3. Necrotising enterocolitis

  4. Days to regain birth weight

  5. Invasive infection

  6. Duration of hospital stay

Notes Human milk was enriched with a multi‐nutrient fortifier when infants reached an intake volume of volume of 100 mL/kg/day.
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 Complete.
Selective reporting (reporting bias) Low risk All outcomes on trial registry reported. Additional data not specified as outcomes in trial registry also reported as secondary outcomes (necrotising enterocolitis, days to regain birth weight, discharge weight, hyperglycaemia, hypoglycaemia, patent ductus arteriosus, apnoea, duration of antibiotics, duration of intravenous fluids, intraventricular haemorrhage, shock).
Other bias Unclear risk Funding source not reported.