NCT03387579View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2018

Primary Completion Date

March 28, 2021

Study Completion Date

March 19, 2024

Conditions
Cholestasis of Parenteral Nutrition
Interventions
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

Trial Locations (1)

46202

Riley Hospital for Children at IU Health, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER

NCT03387579 - Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates | Biotech Hunter | Biotech Hunter