drugset / Trial / NCT03387579

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

NCT03387579

Phase 3 Completed 24 enrolled Indiana University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2018-11-30
Primary completion
2021-03-28
Completion
2024-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Intralipid Other / unclassified 1 g/kg Intravenous
Subject Intralipid Other / unclassified 2 g/kg Intravenous
Subject Intralipid Other / unclassified 3 g/kg Intravenous
Subject SMOFlipid Other / unclassified 3 g/kg Intravenous