Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Recruiting
Phase 4
Interventional Study
Malnutrition, Child
Malnutrition
Essential Fatty Acid Deficiency (EFAD)
Parenteral Nutrition Associated Cholestasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 17
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 100 (estimated)
- Sponsor
- Fresenius Kabi · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Age Limits: and Adults
Inclusion Criteria:
1. Male or female patients, at least 1 month of age.
2. Patients who require PN for at least 5 days/week.
3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total…
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