Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age - Trial NCT03563222
Access comprehensive clinical trial information for NCT03563222 through Pure Global AI's free database. This Phase 4 trial is sponsored by Fresenius Kabi and is currently Terminated. The study focuses on Malnutrition, Child. Target enrollment is 1 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Fresenius Kabi
Timeline & Enrollment
Phase 4
Dec 18, 2019
Jul 08, 2022
Primary Outcome
Body Weight,Body Height,Head Circumference,Fatty Acid Profile in Total Plasma,Fatty Acid Profile in Red Blood Cell Membranes,Triene/Tetraene Ratio,Number of Patients in Each Treatment Group With Direct Bilirubin Levels 2 mg/dL,Time Until Reaching Direct Bilirubin Levels 2 mg/dL,Sterols in Plasma Including Phytosterols,Change From Baseline Triglycerides,Change From Baseline Urea Nitrogen,Change From Baseline Alanine Aminotransferase (ALT),Change From Baseline Aspartate Aminotransferase (AST),Change From Baseline Direct Bilirubin,Change From Baseline Total Bilirubin,Change From Baseline Gamma-glutamyl Transferase (GGT),Change Form Baseline Alkaline Phosphatase (ALP),Change From Baseline Creatinine,Change From Baseline Electrolytes (Na, K, Mg, Cl,Ca, Phosphate),Change From Baseline Trace Elements (Ferritin, Zn, Se, Cu, Mn, Cr),Change From Baseline Glucose,Change From Baseline Total Protein,Change From Baseline C-reactive Protein (CRP),Change From Baseline White Blood Cell (WBC) Count,Change From Baseline Red Blood Cell (RBC) Count,Change From Baseline Platelet Count,Change From Baseline Hemoglobin,Change From Baseline Hematocrit,Change From Baseline International Normalized Ratio (INR),Change From Baseline Sterols (Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Ergosterol, Cholesterol, Desmosterol, Lanosterol, Beta-sitostanol, Lathosterol, Squalene),Vital Signs: Blood Pressure,Vital Signs: Heart Rate,Vital Signs: Body Temperature,Adverse Events,Genetic Polymorphisms of Fatty Acid Desaturase Genes FADS1 and FADS2
Summary
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion
 Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of
 age who require parenteral nutrition for at least 90 days and up to 1 year.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03563222
Non-Device Trial