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

Sanghvi 2013.

Study characteristics
Methods Randomised controlled trial
Participants 46 VLBW infants (1200–1500 g birth weight), irrespective of gestational age at birth
Setting: Prince Aly Khan Hospital, Mumbai, India
Interventions Intervention (n = 23): full enteral feeds (80 mL/kg/day) with expressed maternal milk or preterm formula
Control (n = 23): minimal enteral feeds (20 mL/kg/day) supplemented with parenteral nutrition
Feed volumes increased by 20 mL/kg/day as tolerated
Outcomes
  1. Days to regain birth weight

  2. Feed intolerance (feed volume reduce if 6‐hourly gastric aspirate > 30% of prior feed volume, increase in abdominal girth, vomiting)

  3. Necrotising enterocolitis (not defined – no cases in either group)

  4. Invasive infection

  5. 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.
Fewer infants in the intervention group than the control group received respiratory support via a continuous positive airway pressure device.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated (variable block size randomisation, generated by statistician who was not part of the study).
Allocation concealment (selection bias) Low risk Sequentially numbered, sealed opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not masked – carers could not be blinded to treatment allocation because of nature of the study.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described.
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete.
Selective reporting (reporting bias) Low risk Retrospectively registered (2012). All outcomes reported in trial registry reported.
Reported additional outcomes of feeding intolerance, weight at discharge, z‐score of weight at discharge, length and head circumference at discharge.
Other bias Low risk Received no monetary support.

n: number of participants; SD: standard deviation; VLBW: very low birth weight.