SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury

NCT02412566 | Unknown

• 1 other identifier: H-34444
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

While fish-oil lipid emulsions have shown a benefit to the treatment of parenteral nutrition (PN)-associated cholestasis, the dose is limited to 1 g/kg/day. Similarly, in early PN-associated cholestasis the dose of soy-based lipid is limited to 1 g/kg/day. Often the calories that are lost from this relative decreased dose of lipids can be provided by adjusting the dextrose content of the PN solution and providing a higher glucose infusion rate. In some cases, this is not tolerated or even with maximizing this strategy, growth is inadequate. Inadequate growth is a direct cause of poor outcomes including poorer neurological outcome, failure to be able to stop mechanical ventilation and poorer growth of their often already damaged intestine. These outcomes can lead to severe disability and death. Therefore, infants receiving only 1 g/kg/day of lipids who are not adequately growing must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid (Fresenius Kabi, Bad Homburg, Germany) contains a mixture of 4 different lipid sources: soybean oil providing essential fatty acids, olive oil rich in monounsaturated fatty acids which are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides showing a faster metabolic clearance than long-chain triglycerides, and fish oil for the supply of omega-3 fatty acids. It is safe to give in what is the usual dose for lipid therapy in neonates of 3 g/kg/day, rather than being limited to 1 g/kg/day as we do with cholestatic infants receiving Omegaven or soy lipids. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. Purpose: We want to find out if this new intravenous fat mixture (SMOFlipid) will help promote good growth while reducing the severity (or seriousness) of liver disease or help put an end to liver disease in infants.

Conditions

Cholestasis; Growth Failure

Keywords

cholestasis; growth failure; intravenous fat emulsion; SMOF

Interventions

SMOFlipid DRUG

Therapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Also known as: SMOF

Eligibility Criteria

• Age: 14 Days - 1 Year
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Greater than 14 days old and less than 1 year of age.
• Greater than 1.5 kg.
• Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL, or currently receiving Omegaven (fish oil lipid emulsion) with a conjugated bilirubin between 0.0-1.9 mg/dL.
• Currently receiving 1 g/kg/day of either Omegaven (H-23365) or soy-based Intralipid (standard therapy)
• Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
• Be expected to require intravenous nutrition for at least an additional 21 days.

You may not qualify if:

• Have a congenitally lethal condition (e.g. Trisomy 13).
• Have clinically severe bleeding or clinical liver failure not able to be managed with routine measures.
• Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
• Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):81S-94S. doi: 10.1177/0148607111424411.

  PMID: 22237883 BACKGROUND

• Goulet O, Antebi H, Wolf C, Talbotec C, Alcindor LG, Corriol O, Lamor M, Colomb-Jung V. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2010 Sep-Oct;34(5):485-95. doi: 10.1177/0148607110363614.

  PMID: 20852176 BACKGROUND

• Tomsits E, Pataki M, Tolgyesi A, Fekete G, Rischak K, Szollar L. Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. J Pediatr Gastroenterol Nutr. 2010 Oct;51(4):514-21. doi: 10.1097/MPG.0b013e3181de210c.

  PMID: 20531018 BACKGROUND

Related Links

• Children's Nutrition Research Center

MeSH Terms

Conditions

Cholestasis; Failure to Thrive

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muralidhar H. Premkumar, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 9, 2015
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)