Troche 1995.
Methods | Randomised controlled trial | |
Participants | Infants born at 25 to 30 weeks' gestation with respiratory distress, an umbilical artery catheter in situ, and an anticipated need for mechanical ventilation for at least 3 days. Infants with asphyxia or respiratory failure despite ventilatory support were excluded Setting: University of Boston, USA |
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Interventions | Minimal enteral nutrition (N = 16) vs. enteral fasting (N = 13) Infants in the minimal enteral nutrition group received maternal breast milk or standard formula beginning within 24 hours after birth at a rate of 0.5 to 1.0 ml/hour until the umbilical artery catheter was removed. Controls were fasted until the umbilical arterial catheter was removed. Both groups received parenteral nutrition beginning on day 3 |
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Outcomes | Feeding tolerance; days to full enteral feeding Incidence of necrotising enterocolitis Time to regain birth weight Mortality |
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Notes | In infants < 800g at birth, feeds were given by continuous infusion, for those > 800 g feeds were given as boluses | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | High risk | Not stated but likely that care givers and investigators were aware of intervention group after allocation |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 infants developed necrotising enterocolitis but were then subsequently excluded from growth data |