Dollberg 2000.
Methods | Randomised ‐ Yes Blindness of randomisation ‐ Yes. Blindness of intervention ‐ No. Complete follow‐up ‐ No. Blinding of outcome measurement ‐ No. |
|
Participants | 28 infants randomised.
5 post‐randomisation exclusions.
23 infants analysed. Inclusion: AGA, < 48 hours postnatal age, no major congenital malformations, and informed consent. |
|
Interventions | Continuous feeding by syringe pump.
Intermittent feeding by gravity every 2 hours in 501 ‐ 750g group; every 3 hours in other infants. Feeding protocol for each weight group. Protocol to manage feeding intolerance (gastric residual > 20% of the volume fed over the previous 4 hr). Feeds: undiluted human milk, preterm formula, (initially diluted), or both. Timing of Feeds: Protocol was day 2‐5. Actual was not stated. |
|
Outcomes | Days to full feeds (160 mL/kg/day). Days to regain birth weight. Delay between expected time to full feeds vs actual time to full feeds. | |
Notes | Pilot study. Additional data re: intervention, sample size and methodologic criteria provided by investigator as study initially available as abstract (now published). No sample size calculation. 5 post‐randomisation exclusions. Regression analysis suggested mode of feeding as the only variable affecting feeding tolerance. Awaiting subgroup data. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Stratified by birth weight (501 ‐ 750g; 751 ‐ 1000g; 1001 ‐ 1250g). Assigned randomly (using random numbers). The randomisation assignment was performed using sealed opaque envelopes that were grouped in an even blocked design, by the stratification variable (birthweight). |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Investigators were not blinded to the study group assignment, but caregivers responsible for the infants' care and for feeding protocol performance were not part of the investigation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Excluded nine infants from analysis. Of four patients excluded from the continuous group, one had been switched to breastfeeding, but none were excluded for feeding intolerance. Of five infants excluded from the intermittent group, three infants were excluded for protocol violation (feeding intolerance not specified) and one had been switched to breastfeeding. |