Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

Exclusion Criteria

• •1. Patients who are not expected to survive hospitalization or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study
• •2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container
• •3. Patients with a diagnosis of shock, renal failure requiring dialysis, or severe metabolic acidosis (eg, pH \<7.10, serum bicarbonate level ≤15 mEq/L , and/or an Anion Gap \>16 mEq/L)
• •4. Patients with hemodynamic instability as judged by the Investigator
• •5. Patients with uncorrected metabolic disorders (eg, diabetes) or liver disease including cholestasis
• •6. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL)
• •7. Patients who are unable to tolerate the necessary laboratory monitoring
• •8. Patients who have a new and active infection (as assessed by the investigator) at time of initiation of study treatment
• •9. Patients who are enrolled in another clinical trial involving an investigational agent
• •10. Patients who were treated with IV lipids within 48 hours of randomization into the study