Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid

• Published in: JPEN. Journal of parenteral and enteral nutrition Vol. 41; no. 5; p. 866
• Main 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
• Format: Journal Article
• Language: English
• Published: United States 01.07.2017
• Subjects: Bilirubin - blood; Emulsions - therapeutic use; Fat Emulsions, Intravenous - therapeutic use; Female; Humans; Infant; Infant, Newborn; Intestinal Diseases - complications; Intestinal Diseases - therapy; Intestines - drug effects; Intestines - metabolism; Liver Diseases - complications; Liver Diseases - therapy; Male; Parenteral Nutrition, Total; Phospholipids - therapeutic use; Pilot Projects; Soybean Oil - therapeutic use; Treatment Outcome; intestinal failure associated liver disease; intestinal failure; clinical trials; ω-3 fatty acids; intravenous lipid emulsions
• ISSN: 1941-2444
• DOI: 10.1177/0148607115626921

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). 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. 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. Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195.