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

NCT03387579 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1708745276
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cholestasis

  Cholestasis was defined as a direct bilirubin \> 2 mg/dL on two measurements 5 to 7 days apart.

  Patients were monitored during time enrolled in study for a maximum of up to 12 weeks or 84 days.

Secondary Outcomes (19)

• Weight Velocity

  Patient weight was recorded at enrollment, weekly during time enrolled, and at end of study for up to a maximum of 12 weeks. End and enrollment weights were used to calculate velocity.

• Length Velocity

  Length was measured at enrollment, weekly during time enrolled in study, and end of study up to a maximum of 12 weeks. End and enrollment measurements were used for velocity.

• Head Circumference (OFC) Velocity

  OFC was measured at enrollment, weekly, and end of study. Enrollment and end of study measurements used for velocity.

• Average Total Calorie Intake

  Daily calorie intake was recorded and averaged on a weekly basis for duration of study enrollment up to max of 12 weeks.

• Number of Patients With Enteral Autonomy at End of Study

  Enteral autonomy was recorded at the study end point for each individual patient. This end point was at time of stopping study lipid, discharge from hospital, or maximum of 12 weeks.

Study Arms (3)

Smoflipid 20%

EXPERIMENTAL

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.

Drug: Smoflipid 20% Lipid Emulsion for Injection

Intralipid 20% Reduction

EXPERIMENTAL

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.

Drug: Intralipid, 20% Intravenous Emulsion

Intralipid 20% Historic

OTHER

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.

Drug: Intralipid, 20% Intravenous Emulsion

Interventions

Smoflipid 20% Lipid Emulsion for Injection DRUG

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

Smoflipid 20%

Intralipid, 20% Intravenous Emulsion DRUG

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

Also known as: Intralipid 20% Reduction

Intralipid 20% Reduction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current weight less than 750 grams
• AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
• Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
• Severe coagulopathy with INR greater than 95th percentile for age (\>1.7 at less than 5 days of age, \> 1.5 older than five days of age)
• Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
• Renal failure requiring dialysis
• Cyanotic heart disease requiring prostaglandin therapy
• Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

SMOFlipid; Injections; soybean oil, phospholipid emulsion

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Katie Huff
• Organization: Indiana University School of Medicine

huffka@iupui.edu

3179449395

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics, Co-chair, Nutrition Support Team at Riley Hospital for Children, Medical Director, Pediatric Intestinal Rehabilitation Program

Model Details: Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: January 2, 2018
• Study Start: November 30, 2018
• Primary Completion: March 28, 2021
• Study Completion: March 19, 2024
• Last Updated: July 30, 2025
• Results First Posted: August 26, 2022

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)