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Lipid Emulsion

Smoflipid for Child Malnutrition

Phase 4
Waitlist Available
Led By Jeffrey Rudolph, MD
Research Sponsored by Fresenius Kabi
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 from day 1 weekly to day 365
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new lipid emulsion called Smoflipid to the current standard of care, Intralipid 20%, in children ages 3 months to 16 years who require long-term parenteral nutrition.

Eligible Conditions
  • Child Malnutrition

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 weekly to day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 weekly to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Body Height
Body Weight
+32 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SmoflipidExperimental Treatment1 Intervention
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, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3).
Group II: Intralipid, 20%Active Control1 Intervention
Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoflipid
2015
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

Fresenius KabiLead Sponsor
80 Previous Clinical Trials
1,137,367 Total Patients Enrolled
Jeffrey Rudolph, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on participants for this clinical experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research project initially published in December 2019 is actively recruiting for 144 participants at a single medical site. The page was last updated on May 20th 2022."

Answered by AI

Could I potentially qualify for participation in this medical experiment?

"This clinical trial is welcoming 144 patients who display malnutrition and are between 3 months old and 16 years of age."

Answered by AI

To what extent could the administration of Smoflipid be detrimental to patients?

"Considering the fact that Smoflipid has been approved for clinical use, a score of 3 was given to reflect its safety level."

Answered by AI

What indications are usually treated with Smoflipid?

"Smoflipid can be utilized to manage pregnant or postnatal patients, those suffering from ascorbic acid deficiencies, and individuals depending on parenteral nutrition."

Answered by AI

Is patient recruitment for this experiment ongoing?

"This medical trial, which was initially posted on December 18th 2019 and most recently updated on May 20th 2022, is actively accepting participants."

Answered by AI

Can persons aged 20 and above partake in this study?

"Aspiring participants of this study must be between 3 months and 16 years old."

Answered by AI

Could you detail the preceding investigations involving Smoflipid?

"At this time, Smoflipid is the subject of 22 clinical trials. Among those studies, 4 are in Phase 3. Most of these investigations are based in Mexico City but there are 73 different sites that are running research for this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
2019. "Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03563222.
~0 spots leftby Apr 2025
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