Actively Recruiting
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Led by Fresenius Kabi · Updated on 2025-12-04
100
Participants Needed
5
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients at least 1 month old
- Require parenteral nutrition for at least 5 days per week
- Receive 80% or more of total energy from parenteral nutrition at enrollment
- Expected to receive 80% or more of total energy from parenteral nutrition for at least 56 days
- Provide written informed consent; for pediatric patients, consent from parent or legal representative and assent if possible
You will not qualify if you...
- Use of any lipid injectable emulsion other than SMOFlipid within 6 months before study
- Known allergies to fish, egg, soybean, or peanut proteins or any component of SMOFlipid
- Hyperlipidemia with serum triglycerides >250 mg/dL in infants or >400 mg/dL in older children/adults
- Inborn errors of amino acid metabolism
- Cardiopulmonary instability requiring significant vasopressor support
- Hemophagocytic syndrome
- Liver enzymes (AST, ALT, or GGT) more than twice the upper limit of normal
- Direct bilirubin more than twice the upper limit of normal
- INR more than twice the upper limit of normal without oral anticoagulants
- Any hepatic condition (other than IFALD) causing direct bilirubin ≥2.0 mg/dL
- Significant abnormal serum electrolyte levels
- Active bloodstream infection confirmed by positive blood culture
- Severe renal failure (eGFR <15 ml/min/1.73 m2) or on renal replacement therapy
- Abnormal blood pH, oxygen saturation, or carbon dioxide levels
- Pregnancy or lactation
- Participation in another interventional clinical study
- Expected survival less than 56 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
The University of Chicago
Chicago, Illinois, United States, 60638
Not Yet Recruiting
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
5
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
M
Martin Stumpf, PhD
CONTACT
J
Jean-Marc Lohse, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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