Singh 2018.
Methods | RCT | |
Participants | Infants with birth weight 1500 to 2000 g and postnatal age < 48 hours who required gavage feeds were included. Exclusion criteria were perinatal asphyxia (cord blood gas or first blood gas after birth with pH < 7.0 or base excess > –16 mmol/L and Apgar score < 5 at 10 minutes), major congenital malformations/surgical conditions that could interfere with feeding, and severe growth restriction (defined as birth weight below the third percentile) | |
Interventions | Routine assessment of gastric residual was done in both groups Intervention group: Only the quality of gastric residual was assessed. A maximum of 0.5 mL of gastric contents was aspirated before each feed. If the residual was haemorrhagic or was repeatedly bilious (more than 1 time) with or without vomiting or abnormal abdominal examination, feed interruption was done. The volume of gastric residual was not assessed Control group: Both volume and quality of gastric residual were assessed. The entire volume of gastric residual was aspirated before every feed. If the aspirate was > 50% of feed volume or > 3 mL, whichever was greater, feeds were withheld. Also if the aspirate was bloody or bile stained, feeds were withheld |
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Outcomes |
Primary outcome: Time to reach full enteral feeding ≥ 120 mL/kg/d Secondary outcomes: Time to regain birth weight, time to regain 120% of birth weight, incidence of late‐onset culture‐proven sepsis (≥ 72 hours), NEC (Bell stage ≥ 2), number of occasions feedings were discontinued for > 24 hours or were not increased for > 24 hours |
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Notes | Feeds were started on day 1 or later, once the infant was haemodynamically stable. Feeds were started at 3 mL every 3 hours and were increased by 3 mL every 9 hours in infants with birth weight 1500 to 1750 g. For infants with 1751 to 2000 g birth weight, feeds were started at 6 mL every 3 hours and were increased by 3 mL every 6 hours. Infants were fed breast milk if available and preterm formula after parental consent was obtained when breast milk was not available. Feeds were fortified when enteral feeds of 150 mL/kg/d were achieved | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation sequence was computer generated and permuted, even numbered; randomly varying block sizes were generated with a 1:1 allocation ratio |
Allocation concealment (selection bias) | Low risk | The allocation sequence was concealed using serially numbered opaque sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 87 randomised infants were included in the analysis |
Selective reporting (reporting bias) | Low risk | Study protocol had been published. All proposed outcomes were reported |
Other bias | Low risk | Nil |