SMOFlipid to Lessen the Severity of Neonatal Cholestasis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 4/21/2016 |
| Start Date: | April 2016 |
| End Date: | April 2018 |
| Contact: | Josef Neu, MD |
| Email: | neuj@peds.ufl.edu |
| Phone: | 352 273 8985 |
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
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.
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.
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
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