Nehra 2014.

Methods	Design: double‐blind RCT Setting: Boston Children's Hospital, Boston, USA Study enrolment: July 2007 to June 2009 I. Allocation concealment: yes II. Blinding of intervention: yes III. Blinding of outcome measurement(s): yes IV. Complete follow‐up: 2/10 in S‐LE and 3/9 F‐LE (33%) lost to follow‐up All analyses were performed on an ITT basis
Participants	Inclusion criteria: neonates and infants (< 3 months' age) with baseline conjugated bilirubin < 1.0 mg/dL and a gastrointestinal disease requiring surgical intervention who were expected to be PN dependent for ≥ 21 days Exclusion criteria: INR > 1.5 (> 2 if ≤ 1 week of age) or TG level > 400 mg/dL and those with a haemolytic disorder, liver disease or shock requiring vasopressor support, extracorporeal membrane oxygenation, nitric oxide treatment or a combination of these. Infants who had undergone an intestinal lengthening procedure were not eligible.
Interventions	Group 1 (n = 10): S‐LE; Intralipid Group 2 (n = 9): Pure F‐LE; Omegaven
Outcomes	Primary outcome: incidence of cholestasis, defined as a serum conjugated bilirubin > 2 mg/dL for ≥ 2 consecutive weeks Secondary outcomes: neurodevelopmental outcome assessed by BSID‐III (series of motor, cognitive and language scales) at 6 and 24 months' corrected age
Notes	Financial disclosures: supported by the March of Dimes, the Food and Drug Administration Orphan Drugs Division (grant 1 R01FD003436), Children's Hospital Boston Surgical Foundation and The Vascular Biology Program (Boston, MA). C.D. was supported in part by K24HD058795. Trial registered at ClinicalTrials.gov (NCT 00512629).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Following informed consent, patients were randomly assigned by a computer‐generated list of random numbers to the control (SIFE) or experimental (FIFE) group in a 1:1 ratio." Comment: done
Allocation concealment (selection bias)	Low risk	Quote: "Patients, parents, physicians, dieticians, and nurses were blinded to the treatment allocation for the duration of the study. Members of the department of pharmacy were aware of the randomisation and identically packaged the IFEs." Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Patients, parents, physicians, dieticians, and nurses were blinded to the treatment allocation for the duration of the study. Members of the department of pharmacy were aware of the randomisation and identically packaged the IFEs." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Patients, parents, physicians, dieticians, and nurses were blinded to the treatment allocation for the duration of the study. Members of the department of pharmacy were aware of the randomisation and identically packaged the IFEs." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: clinical outcomes were reported for most infants. Secondary outcome: neurodevelopment outcome had 26% loss to follow‐up. By consensus the review authors considered that the overall risk was low.
Selective reporting (reporting bias)	Low risk	Quote: "This trial is registered at clinicaltrials.gov (NCT 00512629)." Comment: protocol was registered at the time of trial initiation and trial was reported in line with the published protocol.
Other bias	Unclear risk	Trial stopped early.