Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
Male or female patients, at least 1 month of age.
Patients who require PN for at least 5 days/week.
Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days.
Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).
Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation
Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.
Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >250 mg/dL in infants or >400 mg/dL in older pediatric and adult patients).
Inborn errors of amino acid metabolism.
Single group
SMOFlipid® (lipid injectable emulsion)
DrugSMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.20 g/mL, and comprises a mixture of soybean oil, MCT, olive oil, and fish oil. SMOFlipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions" (ATC-code: B05BA02). SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Incidence of PNAC
defined as direct bilirubin level \> 2 mg/dL, confirmed by a second sample collected 7 days after the first sample
Time to direct bilirubin > 2mg/dL
(confirmed by a second sample collected 7 days after the first)
Incidence of EFAD
Triene/tetraene ratio in total plasma to assess EFAD (Holman 1960), Severity of EFAD will be graded based on triene/tetraene ratio, as suspected ≥ 0.05, moderate ≥ 0.20 and severe ≥ 0.40 (Cober et al 2012)
Incidence of clinical EFAD
Laboratory values: triglycerides
Laboratory values: direct bilirubin
Laboratory values: total bilirubin
Laboratory values: alanine aminotransferase (ALT)
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