Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 28, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

September 30, 2026

Conditions
Malnutrition, ChildMalnutritionEssential Fatty Acid Deficiency (EFAD)Parenteral Nutrition Associated Cholestasis
Interventions
DRUG

SMOFlipid® (lipid injectable emulsion)

"SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.20 g/mL, and comprises a mixture of soybean oil, MCT, olive oil, and fish oil. SMOFlipid belongs to the pharmacotherapeutic group: Solutions for parenteral nutrition, fat emulsions (ATC-code: B05BA02). SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated."

Trial Locations (4)

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

30322

NOT_YET_RECRUITING

Emory University Hospital, Atlanta

46202

RECRUITING

Riley Hospital for Children, Indianapolis

60638

NOT_YET_RECRUITING

The University of Chicago, Chicago

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY