Akintorin 1997.
| Methods | Randomised ‐ Yes. Blindness of randomisation ‐ Yes. Blindness of intervention ‐ No. Complete follow‐up ‐ No. Blinding of outcome measurement ‐ Can't tell. |
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| Participants | 89 infants randomised. 9 post‐randomisation exclusions.
80 infants analysed. Inclusion: Infants 700‐1250g, haemodynamically stable and ready to start enteral feeds. Exclusion: Apgar score < 3 at 5 minutes, to receive breast milk, documented sepsis, NEC or unable to start feeding before day 10 of life. |
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| Interventions | Feeding did not begin until umbilical arterial catheter removed. Continuous feeding by infusion pump. Intermittent feeding given every 3 hours for 15‐30 minutes by gravity via indwelling feeding tube. Feeding protocol for each 50‐100 g weight category. Protocol to manage feeding intolerance (feeds held > 12 hours). Energy and protein intake kept identical between groups. Feeds: undiluted preterm formula (20 Kcal/oz). Timing of Feeds: Protocol was < 10 postnatal days. Actual for Continuous group was 5.7 +/‐ 2.1 days and for Intermittent group was 5.6 +/‐ 2.2 days. |
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| Outcomes | Primary: Days to full feeds (100 Kcal/kg/d). Secondary: Feeding intolerance, days to regain birth weight, days to discharge weight of 2040 g, NEC, and apnoea (>15 seconds). |
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| Notes | Sample size calculation based on 35% decrease in number of days to full feeds in continuous group. Did not exclude SGA infants. Uncertain when feeds changed from continuous to bolus feeding. Numbers unbalanced. Exclusions: 4 Continuous (none due to protocol violation) and 5 Bolus (3 due to protocol violation). Larger proportion of infants whose feeds were held in the continuous group had residuals, whereas in the bolus group infants had apnea/bradycardia. Guidelines for residuals may allow larger volumes than some other studies. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Stratified according to birth weight into one of two groups (700‐1000g and 1001‐1250g). Randomly assigned within each weight group by using sequentially numbered opaque sealed envelopes using a table of random numbers. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Caregivers not blinded as would not be feasible. |