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

NCT03387579 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-30

Study results available
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Summary

Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction.

Conditions

  • Cholestasis of Parenteral Nutrition

Interventions

DRUG

Smoflipid 20% Lipid Emulsion for Injection

Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day

DRUG

Intralipid, 20% Intravenous Emulsion

Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day

DRUG

Intralipid, 20% Intravenous Emulsion

Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2021-03-28
Completion
2024-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387579 on ClinicalTrials.gov