Kaur 2015.
Methods | RCT | |
Participants | Eighty infants with birth weight < 1500 g were included. Infants with major congenital abnormalities, gestation < 27 or > 34 weeks, absent or reversed end‐diastolic flow in antenatal doppler, or Apgar score < 3 at 5 minutes were excluded | |
Interventions | Infants were randomised into gastric residual volume monitoring group or abdominal circumference monitoring group at the time of initiation of enteral feeds Gastric residual volume monitoring group: Gastric residual volume was measured before each feed. Feed intolerance was defined as presence of 1 or more of the following features: bilious/haemorrhagic aspirates or volume of aspirates > 50% of previous feed or > 3 mL, whichever was larger. If gastric residues were between 30% and 50% of previous feeds, the same volume was continued without making a daily increment. Feeds were advanced as per protocol if gastric residues were < 30% of previous feeds. The gastric residues aspirated were discarded Abdominal circumference monitoring group: Abdominal circumference measurement was performed before each feed using a standard, disposable non‐stretchable paper tape with minimum markings of 1 mm. The tape was positioned 1 cm above the umbilicus and was read along its bottom edge. A mark was made along the lower edge as reference for subsequent measurements. An increase in prefeed abdominal circumference by 2 cm from baseline was considered a sign of feed intolerance. Gastric residual volume assessment was not routinely performed unless the abdominal circumference increased by > 2 cm. The decision for feed interruption was merely based on an increase in abdominal girth. The least abdominal circumference during the previous 24 hours was used as the baseline reference Infants in both groups who experienced feed intolerance were kept nil per oral for the next 24 hours. Once abdominal circumference was less than or equal to baseline (abdominal circumference group) or gastric aspirates were clear and < 10 mL/kg/d (gastric residual volume group), feeds were restarted at 50% of the volume being delivered at the time of feed interruption |
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Outcomes |
Primary outcome: Time taken to achieve full feeds (180 mL/kg/d), which were tolerated for at least 24 hours Secondary outcomes: Incidence of feed intolerance, time taken to regain birth weight, feed interruption days, duration on TPN, incidence of NEC (Bell stage 2), incidence of culture‐positive sepsis, duration of hospital stay, and mortality |
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Notes | The enrolled infants were assessed daily from birth for feed initiation. Feeds were initiated when infants were haemodynamically stable with soft abdomen and audible bowel sounds. Intermittent gavage feeds were given at 2‐hourly intervals. Feed was started at 10 mL/kg in infants < 1250 g and 20 mL/kg in infants ≥ 1250 g. Subsequent advancements were made by 20 mL/kg/d as tolerated, to a maximum volume of 180 mL/kg/d. Expressed mother’s milk was preferred; if not available, standard preterm formula with a calorie content of 80 kcal/100 mL was used. Human milk fortifier was added once infants tolerated 100 mL/kg/d feed volume | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated block randomisation sequence with block size of 4 was prepared by a person not involved in clinical care, measurement of outcomes, or analysis of data |
Allocation concealment (selection bias) | High risk | This randomisation sequence was kept in sequentially numbered sealed opaque envelopes. However, a fixed block size of 4 gives the chance to guess the allocation of every fourth infant in an unblinded study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 80 randomised infants were included in the analysis |
Selective reporting (reporting bias) | Low risk | All proposed outcomes were reported |
Other bias | Low risk | Nil |