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

Hsiao 2018.

Methods Design: double‐blind RCT
Setting: single‐centre NICU in Changhua, Taiwan
Study enrolment: 1 March 2012 to 28 February 2014
I. Allocation concealment: yes
II. Blinding of intervention: yes
III. Blinding of outcome measurement(s): yes
IV. Complete follow‐up: yes (outcomes mentioned till discharge including length of stay)
Participants VLBW infants who were ventilated, recruited within 24 hours of birth
Interventions Group 1: MOFS‐LE; SMOF
Group 2: MS‐LE; Lipovenoes
Both emulsions by Fresenius‐Kabi, Bad Homburg vor der Höhe, Germany
Outcomes Primary outcome: IL‐1b and IL‐6 in serum and BALF. Secondary outcomes: mortality, length of hospital stay, ventilator use days, oxygen‐dependent days, weight gain rate, liver function, PNAC, BPD, ROP, NEC, IVH and late sepsis
Notes Dramatic differences in BPD between groups compared to any other study in the cohort. This could be due to baseline incidence of BPD was high with all ventilated children and study reported complete follow‐up of infants to discharge.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Simple randomisation was done by a hospital pharmacist opening a sealed opaque envelope containing cards."
Comment: study authors did not describe method of random sequence generation.
Allocation concealment (selection bias) Low risk Quote: "pharmacist prepared lipid emulsion syringes (without labels describing their contents) and which were identical in appearance and color."
Comment: acceptable
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "lipid emulsion syringes (without labels describing their contents) and which were identical in appearance and colour," "The physicians and nurses did not know to which group the patients had been allocated."
Comment: acceptable blinding as per the description
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "lipid emulsion syringes (without labels describing their contents) and which were identical in appearance and colour," "The physicians and nurses did not know to which group the patients had been allocated."
Comment: acceptable blinding of outcome assessment for the healthcare providers
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: low risk of attrition with near complete outcome data
Selective reporting (reporting bias) Unclear risk Quote: "Study was retrospectively registered at Current Controlled Trials: ISRCTN11427103 after the study had finished."
Comment: we could not find any deviation from the protocol due to retrospective registration.
Other bias Low risk Comment: none