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Lipid Emulsion

Smoflipid vs Soy-based Lipids for Infant Cholestasis

Phase 3

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neonates with anticipated need for parenteral nutrition for greater than or equal to four weeks and one of the following diagnoses: Anatomic - Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus with or without intestinal resection; Ischemic/perforation - Neonates with spontaneous intestinal perforation or necrotizing enterocolitis requiring surgical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up alt measured at enrollment and every 2 weeks for max 12 weeks.

Awards & highlights

Study Summary

This trial will compare two different strategies for preventing a cholestatic liver disease that can occur in infants who need parenteral nutrition for a prolonged period of time.

Who is the study for?

This trial is for newborns needing nutrition through IV for at least four weeks due to conditions like intestinal issues or surgery. They must weigh over 750 grams, have relatively normal liver tests, and not be severely ill with infections, kidney failure requiring dialysis, certain heart diseases, or very high blood fat levels.Check my eligibility

What is being tested?

The study compares two treatments to prevent liver problems in babies on long-term IV nutrition: a fish oil-based lipid called Smoflipid and a soy-based one known as Intralipid. The goal is to see which is better at preventing cholestasis—a type of liver disease.See study design

What are the potential side effects?

Possible side effects may include reactions related to the infusion such as infection risks or imbalances in blood fats that could affect the baby's health. Each infant might react differently based on their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn will need IV nutrition for 4+ weeks due to a serious intestinal issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ofc was measured at enrollment, weekly, and end of study. enrollment and end of study measurements used for velocity.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ofc was measured at enrollment, weekly, and end of study. enrollment and end of study measurements used for velocity.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ofc was measured at enrollment, weekly, and end of study. enrollment and end of study measurements used for velocity. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Cholestasis

Secondary outcome measures

ALT Change Over Time

AST Change Over Time

Alkaline Phosphatase

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Smoflipid 20%Experimental Treatment1 Intervention

Patients randomized to this arm will receive the composite fish oil lipid, Smoflipid, at standard dosing up to 3 g/kg/day. Patients will be started on a dose of 1 g/kg/day and titrated up to maximum dose. As enteral nutrition is advanced the lipid dose will be weaned per study protocol and dietary recommendations.

Group II: Intralipid 20% ReductionExperimental Treatment1 Intervention

Patients randomized to this arm will receive soy-based lipid (Intralipid) at a dose of 1 g/kg/day throughout their enrollment in the study.

Group III: Intralipid 20% HistoricExperimental Treatment1 Intervention

Patients who retrospectively received soy-based lipid (Intralipid) at standard dosing of 2-3 g/kg/day were eligible for inclusion. Patients in this group were matched to prospective patients based on diagnosis, gestational age, and length of lipid therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intralipid, 20% Intravenous Emulsion

2019

Completed Phase 4

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,137 Total Patients Enrolled

Media Library

Intralipid, 20% Intravenous Emulsion (Lipid Emulsion) Clinical Trial Eligibility Overview. Trial Name: NCT03387579 — Phase 3

Cholestasis Research Study Groups: Intralipid 20% Reduction, Intralipid 20% Historic, Smoflipid 20%

Cholestasis Clinical Trial 2023: Intralipid, 20% Intravenous Emulsion Highlights & Side Effects. Trial Name: NCT03387579 — Phase 3

Intralipid, 20% Intravenous Emulsion (Lipid Emulsion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03387579 — Phase 3

Frequently Asked Questions

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

What are the most recent findings on the benefits of Smoflipid 20% Lipid Emulsion?

"There are a total of 25 clinical trials currently underway that are researching Smoflipid 20% Lipid Emulsion for Injection. Out of these 25 trials, 5 are in Phase 3. Additionally, 78 different locations around the world are running these clinical trials."

Answered by AI

What is Smoflipid 20% Lipid Emulsion for Injection's primary purpose?

"Smoflipid 20% Lipid Emulsion for Injection is most often used to care for pregnant or postnatal patients. However, it can also be used as ascorbic acid deficiency treatment, for total parenteral nutrition, or for general nutritional supplementation."

Answered by AI

Has the FDA cleared Smoflipid 20% Lipid Emulsion for Injection for public use?

"Smoflipid 20% Lipid Emulsion for Injection is currently being trialled in Phase 3 clinical trials. This suggests that there is some supportive data for its efficacy, as well as multiple rounds of data affirming its safety. Our team has given it a rating of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

Charles P.B. Vanderpool 2018. "Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03387579.