SMOFlipid to Lessen the Severity of Neonatal Cholestasis
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
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.
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.
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