Schanler 1999.
Methods | Randomised ‐ Yes Blindness of randomisation ‐ yes. Blindess of intervention ‐ no. Complete follow‐up ‐ yes. Blinding of outcome measurements ‐ can't tell. |
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Participants | 171 infants randomised. Inclusion: 26 to 30 weeks gestation, AGA, postnatal age < or = 96 hours, no congenital anomalies, fraction of inspired oxygen < 0.6 by 72 hours, and written informed consent. Removed infants from treatment protocol if unable to adhere to feeding protocol for > 1 week. |
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Interventions | GI priming vs no enteral intake day 4 to 14 and continuous vs bolus nasogastric tube feedings. 4 Groups: NPO continuous, NPO bolus, GI priming continuous, and GI prime bolus. Bolus feeding given every 3 hours over 20 minutes. Continuous feeding method not described. Feeding protocol for infants. Protocol to manage feeding intolerance based on excess gastric residual volume. Nutrient intakes similar between groups. Feeds: undiluted human milk or initially diluted preterm infant formula. Timing of Feeds: Protocol was 4 ‐ 14 days. Actual was 6 ‐ 16 days. | |
Outcomes | Primary: time to full oral feeding (8 breast/bottle feeding per day). Secondary: days to full enteral feeding (150cc/kg/d), weight gain, head circumference gain, length gain, skinfold thickness (5 sites), feeding intolerance, NEC, apnoea (>20 seconds), nutritional balance studies, bone mineral content and serum indices of protein and mineral status. |
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Notes | Data comparing continuous vs intermittent groups obtained from investigator.
Intent‐to‐treat analysis. Sample size calculation based on a 2 week difference in the time to full oral feeds. Infants randomised to early vs late enteral feeds (day 4 vs 14). 11 infants switched protocol (10 continuous and 1 bolus). Observed greater incidence of residuals with continuous feeds, and more infants unable to adhere to feeding protocols. Infants in the intermittent bolus feeding group ‐ tube placement predominantly (> 90%) orogastric (personal communication). Small sample size given the number of effects being examined (NPO, early feeding, and stratification of gestation age and feed type). Have established criteria for transition to oral feeds, however, not well described, some criteria subjective (e.g. favourable oral motor assessment, increased apnoea, or oxygen needs). Methods section states "The assigned orogastric/nasogastric tube‐feeding method (continuous vs bolus) was maintained throughout the three phases". There is no further mention of tube placement, and no way to know how the babies were in the intermittent group were fed. Awaiting subgroup data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Stratified by gestational age (26‐27 vs 28‐30 weeks) and by diet (human milk vs preterm formula) and assigned randomly among four treatment combinations in a balanced two‐way design where the two treatments were the use of GI priming versus "non per os", or no enteral intake (NPO) from day 4 through 14 after birth and the method of tube‐feeding, continuous infusion versus bolus. Randomisation was performed using sealed opaque envelopes that were grouped, in an uneven blocked design, by stratification variables (gestational age, intent to feed human milk). |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Caregivers not blinded as would not be feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | To ensure the objective assessment of the major outcome variable, the time required by the infant to attain full oral feeding (8 breast and/or bottle feedings per day), oral‐motor function was assessed serially, using a method designed specially for this study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Complete follow‐up. Infants were removed from the treatment protocol if they were not able to adhere to the feeding protocol for more than one week. Ten infants in the continuous group and one in the intermittent group were removed from their assigned feeding protocols because of feeding intolerance. However, data from these infants were included in the analysis. |