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SMOFlipid to Lessen the Severity of Neonatal Cholestasis

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Disease Information

Descriptive Information
Brief Title † SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Official Title † Compassionate Use of an Intravenous Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil for Neonates With Parenteral Nutrition Induced Liver Injury
Brief Summary Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants. Inadequate growth is directly related to poor neurological outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's already damaged intestine. Ultimately, these outcomes can lead to severe disability and death. To mitigate these deleterious effects and optimize growth, parenteral nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. 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. The aim of this research study is to determine if the unique formulation of SMOFLipid will cause less hepatic inflammation compared to soy only intralipids.
Detailed Description The neonates who are being treated at the University of Florida Health Neonates Intensive Care Unit and are anticipated to need more than 21 days of intravenous nutrition will be considered as potential subjects. These subjects will receive the unique formulation of SMOFLipid The following data will be collected from the subject's EMR by members of the research team: - Lab values that evaluate liver function - Growth parameters like head circumference, length, weight - Medical/surgical history - Time to resolution of bilirubin, time to liver transplant, time to death - Length of hospital stay - Rates of blood infections Subjects will remain on SMOFlipid until weaned from PN.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary Outcome Measure † Inflammation of the liver between the groups
Secondary Outcome Measure † Measurement of head circumference for growth increase
Condition † Cholestasis Jaundice, Obstructive
Intervention † DrugSMOFlipid
Study Arms / Comparison Groups SMOFlipid Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 2
Start Date † May 2016
Completion Date December 2016
Primary Completion Date December 2016
Eligibility Criteria † Inclusion Criteria: - Greater than 14 days old and less than 1 year of age. - Greater than 1 kg. - Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL - Currently standard therapy with soy-based Intralipid - 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. - 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
Gender Both
Ages 23 Weeks - 1 Year
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02721277
Organization ID IRB201600068
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Florida
Collaborators ††
Investigators † Principal Investigator: Josef Neu, MD, University of Florida
Information Provided By
Verification Date December 2016
First Received Date † February 23, 2016
Last Updated Date December 21, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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