Preventing the Progression of Intestinal Failure–Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid. (2nd February 2016)

• Record Type: Journal Article
• Authors: Diamond, Ivan R.; Grant, Robert C.; Pencharz, Paul B.; de Silva, Nicole; Feldman, Brian M.; Fitzgerald, Peter; Sigalet, David; Dicken, Bryan; Turner, Justine; Marchand, Valerie; Ling, Simon C.; Moore, Aideen M.; Avitzur, Yaron; Wales, Paul W.
• Is Part Of: JPEN, Journal of parenteral and enteral nutrition. Volume 41:Number 5(2017)
• Page Start: 866
• Page End: 877
• Publication Date: 2016-02-02
• Subjects: intestinal failure -- intestinal failure associated liver disease -- ω‐3 fatty acids -- intravenous lipid emulsions -- clinical trials; Parenteral feeding -- Periodicals; Enteral feeding -- Periodicals; 615.85484
• DOI: 10.1177/0148607115626921
• Languages: English
• ISSNs: 0148-6071

Abstract

Abstract : Background : To examine whether SMOFlipid prevents progression of intestinal failure–associated liver disease (IFALD) in parenteral nutrition (PN)–dependent infants with early IFALD (conjugated bilirubin 17–50 µmol/L, 1‐3 mg/dL). Study Design : Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin. Results : Twenty‐four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment ( P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, –59 µmol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 µmol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups. Conclusions : Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered atclinicaltrials.gov as NCT00793195.