Conditions: Essential Fatty Acid Deficiency (EFAD)
Keywords: Essential Fatty Acids (EFA) Parenteral Nutrition Clinolipid/Clinoleic Parenteral Nutrition Associated Cholestasis (PNAC) Parenteral Nutrition Associated Liver Disease (PNALD) Intestinal Failure Associated Liver Disease (IFALD) Phytosterols Intralipid Infants/Preterm Infants FADS1 and FADS2 Short Bowel Syndrome Cancer Nutrition Olive Oil Emulsion Soybean Oil Emulsion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines. arm 2: Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Interventions: intervention 1: Clinolipid intervention 2: Intralipid
Intervention descriptions: intervention 1: None intervention 2: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Protocol document: