Status: Recruiting
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
Participants needed: 100
Trial details
Phase: Phase 4Age: 1-17Biological sex: AllType: InterventionalSponsor: Fresenius KabiUpdated: Dec 4, 2025Locations: 5
Eligibility criteria
Male or female patients, at least 1 month of age. [+3]
Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior... [+16]