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Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and/or Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment

NCT06049680•Fresenius Kabi

View on ClinicalTrials.gov

Summary

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

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age Limits: and Adults
•1. Male or female patients, at least 1 month of age.
•2. Patients who require PN for at least 5 days/week.
•3. 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.
•4. 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).

Exclusion Criteria

•1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation
•2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.
•3. 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).
•4. Inborn errors of amino acid metabolism.
•5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
•6. Hemophagocytic syndrome.
•7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range
•8. Direct bilirubin exceeding 2 x upper limit of normal range
•9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants.
•10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg/dL.
+7 more criteria

Locations (5)

Emory University Hospital

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

October 28, 2024

Primary Completion Date

March 1, 2026

Completion Date

September 1, 2026

Last Updated

December 4, 2025

Enrollment

100

ESTIMATED participants

Conditions

Malnutrition, ChildMalnutritionEssential Fatty Acid Deficiency (EFAD)Parenteral Nutrition Associated Cholestasis

Interventions

SMOFlipid® (lipid injectable emulsion)

DRUG

Contacts

Martin Stumpf, PhD

CONTACT

+49 6172 686 martin.stumpf@fresenius-kabi.com

Jean-Marc Lohse, PhD

CONTACT

+49 6172 686 Jean-Marc.Lohse@fresenius-kabi.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Choline to Improve Malnutrition and Enhance Cognition

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