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 |
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| 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 |
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| Outcomes |
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| 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. |
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| 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.