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

Study on SMOFlipid safety for EFAD and PNAC risk in patients.

Recruiting
1-17 years
All
Phase 4
This study is a **safety check** for a medicine called **SMOFlipid**. It looks at its effects on patients needing food through a tube for at least 8 weeks. This is called **parenteral nutrition (PN)**, which means getting nutrients directly into the blood. The study wants to see if patients might develop problems like **EFAD** (essential fatty acid deficiency) or **PNAC** (parenteral nutrition-associated cholestasis), which are conditions related to nutrition and liver function. **Who can join?** Patients older than 1 month who need PN, getting most of their food this way, can join. They must have written consent from themselves or a guardian. **Who cannot join?** People who have allergies to fish, egg, soybean, or peanuts, or have certain health issues like liver or heart problems, or are pregnant, cannot participate. **Key Points:** - **Study Length:** 8 weeks or longer with regular check-ups. - **Visits:** Frequent visits to assess health and nutrition. - **Risks:** Possible side effects include liver issues and nutrient deficiencies. **Important:** Always discuss with your doctor if this study is right for you.
Study details
    Malnutrition
    Child
    Malnutrition
    Essential Fatty Acid Deficiency (EFAD)
    Parenteral Nutrition Associated Cholestasis

NCT06049680

Fresenius Kabi

25 April 2026

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