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. 2019 Jun 4;2019(6):CD013163. doi: 10.1002/14651858.CD013163.pub2

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)
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.
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.
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.