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

NCT ID: NCT03387579

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2024-03-19

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.

Detailed Description

Intestinal failure associated liver disease (IFALD) is a cholestatic liver disease associated with prolonged need for parenteral nutrition. This disease can lead to such serious complications as liver failure and need for transplantation. In the neonatal population, short bowel syndrome, due to intestinal resection, is the most common cause of intestinal failure. While the exact cause is yet to be determined, it is felt the lipid component of parenteral nutrition is a large contributor to the development of this disease. Currently, there is no standard preventative strategy to attempt to decrease the risk of IFALD in the high risk, post-surgical neonatal population. The investigators aim to complete a randomized trial comparing two possible preventative strategies. One group will receive a composite lipid containing fish oil (Smoflipid) and the other group will receive soy-based lipid at reduced dosing.

Conditions

Cholestasis of Parenteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Smoflipid 20%

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 Type: EXPERIMENTAL

Smoflipid 20% Lipid Emulsion for Injection

Intervention Type: DRUG

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

Intralipid 20% Reduction

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 Type: EXPERIMENTAL

Intralipid, 20% Intravenous Emulsion

Intervention Type: DRUG

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

Intralipid 20% Historic

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.

Group Type: OTHER

Intralipid, 20% Intravenous Emulsion

Intervention Type: DRUG

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

Interventions

Smoflipid 20% Lipid Emulsion for Injection

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

Intervention Type: DRUG

Intralipid, 20% Intravenous Emulsion

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

Intervention Type: DRUG

Intralipid, 20% Intravenous Emulsion

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

Intervention Type: DRUG

Other Intervention Names

Intralipid 20% Reduction; Intralipid 20% Historic

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Charles P.B. Vanderpool

Assistant Professor of Clinical Pediatrics, Co-chair, Nutrition Support Team at Riley Hospital for Children, Medical Director, Pediatric Intestinal Rehabilitation Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1708745276

Identifier Type: -

Identifier Source: org_study_id