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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Fresenius Kabi
Study ID
NCT06049680
Phase
PHASE4
Status
Recruiting
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Conditions

  • Essential Fatty Acid Deficiency (EFAD)
  • Malnutrition
  • Malnutrition, Child
  • Parenteral Nutrition Associated Cholestasis

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • SMOFlipid® (lipid injectable emulsion) — DRUG
    SMOFlipid 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.

Study Details

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.

Key Dates

Start date
Oct 28, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Single arm SMOFlipid® (lipid injectable emulsion)
    Investigational drug: SMOFlipid® (lipid injectable emulsion).

Primary Outcome Measure

Incidence of PNAC [ Time Frame: Start of Treatment until After End of Last Study PN Duration of Treatment: Study treatment will last for a minimum of 8 weeks (56 consecutive days) and as long as PN is indicated, up to 1 year (365 consecutive days). ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Thomas R. Ziegler, M.D.
[email protected]
404-727-7351
The University of ChicagoChicagoIllinois60638
Edwin R. McDonald, M.D.
[email protected]
(773) 702-3075
Riley Hospital for ChildrenIndianapolisIndiana46202
Charles Vanderpool, MD
[email protected]
317-944-2078
Nationwide Children's HospitalColumbusOhio43205
Ethan Mezoff, Dr.
[email protected]
614 722 2286
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224
Jeffrey Alan Rudolph, MD
[email protected]
7248144905

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GAThe University of Chicago· Chicago, ILRiley Hospital for Children· Indianapolis, INNationwide Children's Hospital· Columbus, OHChildren's Hospital of Pittsburgh of UPMC· Pittsburgh, PA

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