| Methods |
Randomised controlled trial |
| Participants |
60 preterm infants < 1500 grams and < 32 weeks, dependent on oxygen at more than 28 days of age |
| Interventions |
Standard formula (24 kcal/oz) at 180 mL/kg/day compared to high nutrient‐density formula (30 kcal/oz) at 145 mL/kg/day |
| Outcomes |
Growth variables, respiratory outcomes. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Pre‐determined randomisation sequence in block of 4 and 6. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation sequences maintained in opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not feasible to mask the intervention. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Outcome measures done by a research nurse not blind to the dietary randomisation. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All subjects accounted for in the results. |
| Selective reporting (reporting bias) |
Unclear risk |
No published or registered protocol was found. |
| Other bias |
Unclear risk |
The lack on concealment may have had an impact on the intervention itself: the medical staff were apparently reluctant to increase daily fluids, so the high‐volume group did not receive as much fluid as planned. |
| Funding Source |
Unclear risk |
Study was funded by industry (Ross Laboratories) who also created the formulae. No indication is given about other roles of the funding source. |
