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Published on: September 20, 2019
Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid
Ivan R Diamond1, Robert C Grant1, Paul B Pencharz1
11 Hospital for Sick Children, Toronto, Ontario, Canada.
Insights
SMOFlipid effectively reduces liver disease progression in infants with intestinal failure. This lipid emulsion is a safer alternative to Intralipid for parenteral nutrition, improving outcomes in infants with IFALD.
Area of Science:
- Pediatric Gastroenterology
- Hepatology
- Clinical Nutrition
Background:
- Intestinal failure-associated liver disease (IFALD) is a serious complication in parenteral nutrition (PN)-dependent infants.
- Early IFALD is characterized by elevated conjugated bilirubin levels (17-50 µmol/L).
- Identifying effective interventions to prevent IFALD progression is crucial for improving infant outcomes.
Purpose of the Study:
- To evaluate whether SMOFlipid, a fish oil-based lipid emulsion, can prevent the progression of IFALD in infants with early-stage disease.
- To compare the efficacy and safety of SMOFlipid against Intralipid in this vulnerable patient population.
Main Methods:
- A pilot, multicenter, blinded, randomized controlled trial was conducted.
- Infants with early IFALD received either SMOFlipid or Intralipid as their lipid source in PN for up to 12 weeks.
- The primary outcome was the change in serum conjugated bilirubin levels.
Main Results:
- SMOFlipid treatment resulted in significantly lower serum conjugated bilirubin levels compared to Intralipid.
- Infants receiving SMOFlipid were more likely to achieve a conjugated bilirubin level of 0 µmol/L.
- No significant differences in the time to achieve full enteral tolerance or in safety outcomes were observed between the groups.
Conclusions:
- SMOFlipid demonstrates a reduced risk of progressive IFALD in children with intestinal failure compared to Intralipid.
- SMOFlipid represents a promising therapeutic option for managing IFALD in PN-dependent infants.
- Further research may confirm these findings in larger trials.
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 at clinicaltrials.gov as NCT00793195.
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