Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Condition: Malnutrition, Child
MeSH terms: Malnutrition; Child Nutrition Disorders
Intervention: Smoflipid; Intralipid, 20%
Intervention description: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.; The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
Intervention MeSH terms: Soybean oil, phospholipid emulsion; SMOFlipid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 3 Months
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Parenteral nutrition; Pediatrics; Malnutrition; Nutritional needs

Summary:

      Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion
      Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of
      age who require parenteral nutrition for at least 90 days and up to 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients 3 months to 16 years of age.

          2. Patients who require PN for at least 5 days/week.

          3. Patients who receive 60% or more of their total energy requirements as PN at
             enrollment and who are expected to receive 60% or more of their total energy
             requirements as PN for at least 90 days.

          4. Written informed consent from parent(s) or legal representative(s). If possible,
             patient assent must also be obtained (according to local law).

        Exclusion Criteria:

          1. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the
             active ingredients or excipients of Smoflipid or Intralipid 20%.

          2. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia
             (serum triglyceride concentration > 250 mg/dL).

          3. Inborn errors of amino acid metabolism.

          4. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency,
             myocardial infarction, acidosis and hemodynamic instability requiring significant
             vasopressor support).

          5. Hemophagocytic syndrome.

          6. Liver enzymes (either AST, or ALT, or GGT) exceeding 5 x upper limit of normal range

          7. Direct bilirubin ≥ 2.0 mg/dl

          8. INR > 2.

          9. Any known hepatic condition outside of Intestinal Failure-Associated Liver Disease
             (IFALD) that will increase direct bilirubin ≥ 2.0 mg/dl.

         10. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium,
             magnesium, calcium, chloride, phosphate).

         11. Active bloodstream infection demonstrated by positive blood culture at screening.

         12. Severe renal failure including patients on renal replacement therapy.

         13. Abnormal blood pH, oxygen saturation, or carbon dioxide.

         14. Pregnancy or lactation.

         15. Participation in another clinical study.

         16. Unlikely to survive longer than 90 days.