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SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury (SMOF)

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ClinicalTrials.gov Identifier: NCT02412566
Expanded Access Status : Available
First Posted : April 9, 2015
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Muralidhar Premkumar, Baylor College of Medicine

Study Description
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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.


Condition or disease Intervention/treatment
Cholestasis Growth Failure Drug: SMOFlipid

Detailed Description:

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. The same standards of care provided to all patients receiving parenteral nutrition (PN) solution will be followed.

Essential fatty acid levels will be measured at 4 and 12 weeks after the initiation of SMOFlipid. This time frame will be used to assess essential fatty acids of both inpatients and outpatients. These labs are clinically indicated; therefore, we will record the results of the total fatty acid lipid profile panel from the medical record into our case report forms.

Patients will remain on SMOFlipid until weaned from PN. In the event that a patient who has been listed for a liver or liver/intestinal transplant has an organ become available, the participation in this protocol will not preclude them from receiving the transplant. SMOFlipid will not be administered post transplant.

If the infant no longer is requiring any PN, then the SMOFlipid will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires PN, then the SMOFlipid will be continued up until the infant no longer requires PN. The reason for stopping SMOFlipid when the infant no longer requires PN is that this would be the only reason many infants would still need IV access and therefore the risk of maintaining IV access only for the medication is likely to exceed the benefit of SMOFlipid at that point.

Babies who receive SMOFlipid are not precluded from receiving Omegaven per that compassionate use protocol (H-23365) if they meet the inclusion criteria for that protocol.

Study Design
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Study Type : Expanded Access
Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Children With Parenteral Nutrition Induced Liver Injury

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: SMOFlipid
    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.
Eligibility Criteria
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Ages Eligible for Study:   14 Days to 1 Year   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412566


Contacts
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Contact: Muralidhar H. Premkumar, MD 8328267980 premkuma@bcm.edu
Contact: Laura A Gollins, RD 8328263639 laromig@texaschildrens.org

Locations
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United States, Texas
Baylor College of Medicine / Texas Children's Hospital Available
Houston, Texas, United States, 77030
Contact: Muralidhar H. Premkumar, MD    832-826-7980    premkuma@bcm.edu   
Sub-Investigator: Amy Hair, MD         
Principal Investigator: Murali Premkumar, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Muralidhar H. Premkumar, MD Baylor College of Medicine
More Information
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Additional Information:

Publications:

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Responsible Party: Muralidhar Premkumar, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02412566    
Other Study ID Numbers: H-34444
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Keywords provided by Muralidhar Premkumar, Baylor College of Medicine:
cholestasis
growth failure
intravenous fat emulsion
SMOF
Additional relevant MeSH terms:
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Cholestasis
Failure to Thrive
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
 SMOFlipid
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions