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 |
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| 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 |
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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. | |
| 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. |