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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02412566


Primary Contact:

Principal Investigator
Muralidhar H. Premkumar, MD
Baylor College of Medicine

Muralidhar H. Premkumar, MD
Phone: 8328267980
Email: premkuma@bcm.edu


Backup Contact:

Email: laromig@texaschildrens.org
Laura A Gollins, RD
Phone: 8328263639


Location Contact:

Houston, Texas 77030
United States

Muralidhar H. Premkumar, MD
Phone: 832-826-7980
Email: premkuma@bcm.edu

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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