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Composite Parenteral Nutrition Lipid Emulsion

2) SMOFlipid for Intestinal Failure

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 4, 12 and 16 weeks
Awards & highlights

Study 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
  • Short Bowel Syndrome
  • Gastroparesis
  • Mucosal Enteropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 12 and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 12 and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean serum conjugated bilirubin (umol/L)
Secondary outcome measures
Biochemical outcomes shall assess mean levels of "hepatic markers" (AST, ALT, ALP, GGT), coagulation parameters (PT, PTT, INR, platelets), serum lipid levels (triglycerides and cholesterol), serum albumin, and Nephelometry (lipid clearance).
Degree of enteral tolerance (%)
Feasibility of trial (recruitment, protocol adherence, estimated effect size
+4 more

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
686 Previous Clinical Trials
6,944,769 Total Patients Enrolled
3 Trials studying Intestinal Failure
448 Patients Enrolled for Intestinal Failure
Fresenius KabiIndustry Sponsor
80 Previous Clinical Trials
1,137,344 Total Patients Enrolled
Paul WalesPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?
2009. "Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00793195.
All > Liver Fibrosis
~1 spots leftby Apr 2025
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