Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
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
Outcome
Missed primary endpoint
registry analysis (superiority test); Smoflipid 20% vs Intralipid 20% Reduction; p = 0.590; Fisher Exact NCT03387579 ↗
registry analysis (superiority test); Smoflipid 20% vs Intralipid 20% Historic; p = 0.224; Fisher Exact NCT03387579 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |