At a glance
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Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
In Brief
A Phase 3 clinical trial evaluating Smoflipid 20% Lipid Emulsion for Injection and Intralipid, 20% Intravenous Emulsion for Cholestasis of Parenteral Nutrition. Completed, enrolled 24 participants across 1 site.
Detailed Summary
Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.
Study Details
Timeline
Interventions
Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day
Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day