Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
Condition: Essential Fatty Acid Deficiency (EFAD)
Intervention: Clinolipid; Intralipid
Intervention description: Lipid injectable emulsion, USP 20%; Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 0 Years
Maximum age: 17 Years
Healthy volunteers: No
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

Summary:

      This will be a descriptive study designed to evaluate the propensity for hospitalized
      pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7
      up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study
      design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients and/or their legal representative must be able to understand the study and
             voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)

          2. Patients and/or their legal representative accept adherence to protocol requirements

          3. Patients who are expected to require parenteral nutrition (PN)for at least 7 days

          4. Premature infants (born at 24 to <37 weeks of gestation with a birth weight ≥750g)
             require at least 80% of targeted energy requirements by PN at study entry (up to 1
             month CA); full term infants and children require at least 70% of targeted energy
             requirements by PN at study entry

        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.