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Composite Parenteral Nutrition Lipid Emulsion

Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?

Phase 2
Waitlist Available
Led By Paul Wales
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

The aim of this study is to determine the feasibility of conducting a trial to examine the efficacy of an ω3FA (Omega-3 fatty acid) containing balanced lipid emulsion in the prevention of progression of PNALD in infants with Intestinal Failure/Short Bowel Syndrome (SBS) and early liver dysfunction.

Eligible Conditions
  • Intestinal Failure-associated Liver Disease
  • Short Bowel Syndrome
  • Gastroparesis
  • Intestinal Failure
  • Mucosal Enteropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2) SMOFlipidExperimental Treatment1 Intervention
Fat Emulsions for Intravenous Nutrition
Group II: 1) IntralipidActive Control1 Intervention
Fat Emulsions for Intravenous Nutrition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soybean oil
FDA approved

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
712 Previous Clinical Trials
6,959,775 Total Patients Enrolled
Fresenius KabiIndustry Sponsor
81 Previous Clinical Trials
1,137,508 Total Patients Enrolled
Paul WalesPrincipal InvestigatorThe Hospital for Sick Children
~1 spots leftby Jan 2026
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