SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Status:
Terminated
Trial end date:
2017-02-02
Target enrollment:
Participant gender:
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.