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Composite Parenteral Nutrition Lipid Emulsion

2) SMOFlipid for Intestinal Failure-associated Liver Disease

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

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
  • Mucosal Enteropathy
  • Intestinal Failure

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

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
704 Previous Clinical Trials
6,956,853 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 Sep 2025
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