Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-17
SponsorFresenius Kabi

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SMOFlipid® (lipid injectable emulsion)

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators