NCT03387579

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

Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.

Conditions

• Cholestasis of Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	Smoflipid 20% Lipid Emulsion for Injection	Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day
DRUG	Intralipid, 20% Intravenous Emulsion	Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day
DRUG	Intralipid, 20% Intravenous Emulsion	Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day

Timeline

• Start date: 2018-11-30
• Primary completion: 2021-03-28
• Completion: 2024-03-19
• First posted: 2018-01-02
• Last updated: 2025-07-30
• Results posted: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study