Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
Condition: Essential Fatty Acid Deficiency (EFAD)
Intervention: Clinolipid; Intralipid
Intervention description: Standard-of-Care Soybean Oil-Based Lipid Emulsion
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients and/or their legal representative must be able to understand the study and
             voluntarily sign the ICF

          2. Patients age <18 years

          3. Patients who are able to adhere to protocol requirements

          4. Patients who are expected to require PN for at least 7 days

          5. Premature infants (<36 weeks of gestation) require at least 80% PN to meet nutrition
             requirements at study entry; full term infants and children require at least 70% PN to
             meet nutrition requirements at study entry

        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