An Observational Study of SMOFlipid® Versus Intralipid® on the Evolution of Parenteral Nutrition Associated Liver Disease in Neonates with Intestinal Failure
Christina Belza1, John C. Wales1, Glenda Courtney-Martin1, Nicole da Silva1, Yaron Avitzur1,2, Paul W. Wales1,3.
1Group for Improvement of Intestinal Function and Treatment, Hospital for Sick Children, Toronto, ON, Canada; 2Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, Toronto, ON, Canada; 3Division of General and Thoracic Surgery, Hospital for Sick Children, Toronto, ON, Canada
Background: SMOFlipid® has been licensed in Canada in 2013 and has become the standard lipid emulsion for patients managed in our intestinal rehabilitation program (IRP).
Objective: To compare outcomes in neonates with intestinal failure (IF) who received SMOFlipid® compared to Intralipid® to assess outcomes of cholestasis and growth.
Methods: Retrospective cohort study of neonates with intestinal failure (IF) with a follow-up of 12 months. Patients were stratified into two groups [Group 1 (SMOFlipid®) and group 2 (historical cohort who received Intralipid®]. Neonates who were septic at admission were excluded. Patients recruited between Jan 1, 2008 through Dec 31, 2015 with observation period ending Dec 31, 2016. Data collection included demographics, diagnosis, bowel anatomy, and parenteral nutrition (PN) support. The primary outcome was conjugated bilirubin (CB) at 3, 6, 9, 12 months, proportion of patients who developed CB 34, 50, and 100umol/L, proportion of patients who received Omegaven® and were listed and/or received transplantation. Secondary outcomes pertain to growth [z-score for weight and height at 3, 6, 9, 12 months]. Statistical analysis included the Mann-Whitney U and Chi-square with an alpha value of <0.05 considered significant.
Results: 37 patients were evaluated; 17 patients received SMOFlipid® and 20 patients received Intralipid®. There were no differences in demographics, diagnosis, IF category or residual bowel anatomy. There was no difference in percentage of PN support at 3, 6, 9 or 12 months. SMOFlipid patients were less likely to reach CB 34 (24% vs 55%, p=0.05) and 50umol/L (11.8% vs 45%; p=0.028) and did not require Omegaven (0 vs 30%; p=0.014). CB level at 3 months after initiation of PN was lower in patients receiving SMOFlipid (0 vs 36umol/L; p=0.01). Weight Z-scores were improved for patients on SMOFlipid at 3 months (-0.932 vs -2.092; p=0.028) and 6 months (-0.633 vs -1.614; p=0.018). There was no difference between groups for central venous access days or sepsis/1000 catheter days. No patients in either group were listed for transplant.
Conclusion: Neonates with IF who received SMOFlipid® at time of PN initiation, demonstrated lower CB levels over first 12 months. A lower proportion of SMOFlipid® patients reached a CB of 34, 50 and 100umol/L or required Omegaven® rescue. SMOFlipid® delivered at conventional doses appears to slow progression of IFALD while maintaining growth within normal parameters.