D'Ascenzo 2011.
Methods | Design: pilot study Setting: single‐centre NICU of "G. Salesi" Children's Hospital, Ancona, Italy Study enrolment: September 2007 to May 2008 7‐day study primarily looking at the plasma lipids in preterm infants given a new LE containing 10% fish oil, 50% MCTs. Study enrolment: 1 January 2013 to 31 July 2013 I. Allocation concealment: yes II. Blinding of intervention: could not determine III. Blinding of outcome measurement(s): could not determine IV. Complete follow‐up: yes (as per the study design) |
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Participants | Preterm infants bodyweight 500–1249 g, who routinely receive PN from the first hour of life. Exclusion criteria were severe malformations, inborn errors of metabolism and severe sepsis. | |
Interventions | 48 infants < 1250 g were randomly assigned Group 1 (n = 24): MFS‐LE (10:50:40) Group 2 (n = 24): MS‐LE (50:50) LE started at 0.5 g/kg/day, increased by increments of 0.5 g/kg/day to reach 2.5 g/kg/day with 8 mL/kg/day EBM or formula for days 1–4, and then 16 mL/kg/day for days 5–8. Oral feeding was gradually increased from day 9 to reach full oral feeds by day 18, when the TPN was completely tapered. |
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Outcomes | Plasma and RBC FA composition was evaluated on days 7 and 14. Daily weight and weekly head circumference, length were measured with z scores calculated using the Italian reference data. The z scores could not be used to give gram/kg/day for the study as: we had no access to the normative growth charts for Italian children; even with using the growth charts we would not get the correct decimal value by back conversion; we did not have the data on covariance for conversion of growth parameters to rate of growth. |
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Notes | No other clinical outcomes reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "random assignment was performed by sealed envelope system in the first minutes of life." Comment: random component not adequately described. |
Allocation concealment (selection bias) | Low risk | Quote: "random assignment was performed by sealed envelope system in the first minutes of life." Comment: though the envelopes were not described as opaque, guided by the previous studies of the research group, we did not increase the risk. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not mentioned. Though blinding was not mentioned, the outcomes (blood parameters, growth parameters) were objective outcomes and may not have been significantly impacted. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not mentioned. Though blinding was not mentioned, the outcomes (blood parameters, growth parameters) were objective outcomes and may not have been significantly impacted. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: adequate reporting of the outcome data. |
Selective reporting (reporting bias) | Unclear risk | Quote: trial protocol not available. Comment: we could not estimate the risk. |
Other bias | Low risk | Comment: none detected. |