Torrazza 2015.
Methods | RCT | |
Participants | Sixty‐one infants born at postmenstrual age > 23 weeks but ≤ 32 weeks with birth weight ≤ 1250 g and without congenital or chromosomal anomalies or gastrointestinal malformations who were receiving some enteral nutrition by 48 hours of age | |
Interventions |
Infants were randomised before 48 hours of life to: ‐ Routine monitoring of gastric residuals before every feeding ‐ No monitoring of gastric residuals |
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Outcomes |
Primary outcome: Enteral intake at 2 weeks and days to reach 120 mL/kg/d of enteral feedings Secondary outcomes: Enteral intake at 3 weeks, days to reach 150 mL/kg/d, growth indices (weight, head circumference, and length) at 3 weeks, TPN days, CVL days, incidence of NEC, sepsis, and parental nutrition‐associated liver disease |
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Notes | Enteral feeds were started at 20 mL/kg/d and were increased by 20 mL/kg/d. Both human milk and preterm formula were used for feeding. Abdominal distension/discolouration/tenderness, emesis, gastric residual > 50% of the feed volume or bilious aspirates were taken as signs of feed intolerance, and an abdominal radiograph was taken. If the radiograph was normal, feeds were continued; increasing length of feeds to 30 to 50 minutes; decreasing feed volume, or changing to continuous feeds was considered. If the radiograph was abnormal, feeds were withheld for 24 hours followed by reassessment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated block randomisation sequence with variable block sizes was used |
Allocation concealment (selection bias) | Low risk | The randomisation sequence was kept in sequentially numbered sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 61 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 |
CVL: central venous line.
NEC: necrotising enterocolitis.
RCT: randomised controlled trial.
TPN: total parenteral nutrition.