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

Exclusion Criteria

• •1. Patients who are not expected to survive hospitalization or with a severe critical unresponsive illness at time of initiation with foreseeable intercurrent events that could jeopardize the patient's participation in the study, as judged by the Investigator (e.g., unresponsive shock, sepsis, renal failure requiring dialysis, severe unresponsive metabolic acidosis, and/or severe unresponsive metabolic disorders);
• •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 or who have a history of an adverse event due to ILE;
• •3. Patients with liver disease including cholestasis;
• •4. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL);
• •5. Patients who are unable to tolerate the necessary laboratory monitoring;
• •6. Patients who are enrolled in another clinical trial involving an investigational agent;
• •7. Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;
• •8. Premature infants born \<24 weeks of gestation and patients ≥18 years;
• •9. Premature infants with a birth weight \<750 g;
• •10. Patient requires or is expected to require propofol for sedation;
• •11. Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis \<2 months prior and/or symptoms have not resolved.
• •12. Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery
• •13. Female patients who are pregnant. Note: All female patients ≥12 years of age must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening. For female patients \<12 years of age, a urine hCG test at screening will be performed at the discretion of the investigator based on childbearing potential.