Clinical trialNCT06049680RecruitingPhase 4Interventional

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

SponsorFresenius KabiEnrollment100Essential Fatty Acid Deficiency (EFAD)MalnutritionMalnutrition, ChildParenteral Nutrition Associated Cholestasis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jeffrey Rudolph, MD
University of Pittsburgh
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Emory University Hospital
Atlanta, Georgia, United States
Recruiting
the University of Chicago
Chicago, Illinois, United States
Not, yet, recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Recruiting
Nationwide Children'S Hospital
Columbus, Ohio, United States
Recruiting
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SMOFlipid®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Oct 2024
Primary completion: 31 Aug 2026
Completion: 30 Sept 2026
Last update posted: 17 Jul 2026
Registered enrollment: 100
Registry id: NCT06049680

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.