This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Standard-of-Care Soybean Oil-Based Lipid Emulsion
Advocate Children's Hospital
Park Ridge, Illinois, United States
Riley Hospital for Children at Indiana Health
Indianapolis, Indiana, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Medical University of SC, Neonatology
Charleston, South Carolina, United States
Essential Fatty Acid Deficiency (EFAD)
Holman Index Calculation
Time frame: Up to 90 Days
Parenteral Nutrition-Associated Cholestasis (PNAC)
Time frame: Up to 90 Days
Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2
Time frame: Baseline
Fatty Acid Profile
Time frame: Up to 90 Days
Weight
Time frame: Up to 90 Days
Phytosterol, Cholesterol, and Squalene Levels
Time frame: Up to 90 Days
Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)
Time frame: Up to 90 Days
Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake
Time frame: Up to 90 Days
Vital Signs
Time frame: Up to 90 Days
Adverse Events and Serious Adverse Events
Time frame: Up to 30 Days After Subject's Last Study Treatment
Clinical Laboratory Tests
Time frame: Up to 90 Days
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