Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid
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 Intr...
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Published in | JPEN. Journal of parenteral and enteral nutrition Vol. 41; no. 5; p. 866 |
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Main Authors | , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
01.07.2017
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Abstract | 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. |
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AbstractList | 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. |
Author | Diamond, Ivan R Pencharz, Paul B Moore, Aideen M Ling, Simon C Grant, Robert C Sigalet, David Feldman, Brian M Wales, Paul W Turner, Justine Dicken, Bryan Fitzgerald, Peter Marchand, Valerie de Silva, Nicole Avitzur, Yaron |
Author_xml | – sequence: 1 givenname: Ivan R surname: Diamond fullname: Diamond, Ivan R organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 2 givenname: Robert C surname: Grant fullname: Grant, Robert C organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 3 givenname: Paul B surname: Pencharz fullname: Pencharz, Paul B organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 4 givenname: Nicole surname: de Silva fullname: de Silva, Nicole organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 5 givenname: Brian M surname: Feldman fullname: Feldman, Brian M organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 6 givenname: Peter surname: Fitzgerald fullname: Fitzgerald, Peter organization: 2 McMaster Children's Hospital, Hamilton, Ontario, Canada – sequence: 7 givenname: David surname: Sigalet fullname: Sigalet, David organization: 3 Alberta Children's Hospital, Calgary, Alberta, Canada – sequence: 8 givenname: Bryan surname: Dicken fullname: Dicken, Bryan organization: 4 Stollery Children's Hospital, Edmonton, Alberta, Canada – sequence: 9 givenname: Justine surname: Turner fullname: Turner, Justine organization: 4 Stollery Children's Hospital, Edmonton, Alberta, Canada – sequence: 10 givenname: Valerie surname: Marchand fullname: Marchand, Valerie organization: 5 CHU Sainte-Justine, Montreal, Quebec, Canada – sequence: 11 givenname: Simon C surname: Ling fullname: Ling, Simon C organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 12 givenname: Aideen M surname: Moore fullname: Moore, Aideen M organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 13 givenname: Yaron surname: Avitzur fullname: Avitzur, Yaron organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada – sequence: 14 givenname: Paul W surname: Wales fullname: Wales, Paul W organization: 1 Hospital for Sick Children, Toronto, Ontario, Canada |
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Keywords | intestinal failure associated liver disease intestinal failure clinical trials ω-3 fatty acids intravenous lipid emulsions |
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SubjectTerms | 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 |
Title | Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid |
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