Comparison of composite lipid emulsion containing fish oil to soy-based lipid reduction for cholestasis prevention in neonates requiring abdominal surgery
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- STATUS
- Not Recruiting
Summary
Intravenous (or parenteral) nutrition is a necessary treatment for infants who cannot tolerate full feedings by mouth. The prolonged need for parenteral nutrition can lead to serious life threatening complications including liver damage, or intestinal failure associated liver disease (IFALD). Multiple strategies have been proposed to treat and prevent IFALD, but more information is still needed. Through this project we will compare two possible preventative treatment strategies including low does soy-lipid and a multi-component lipid, containing soy, MCT, olive, and fish oils (Smoflipid). This project will be a pilot study to better understand which (or both) strategies may benefit from further study in the future. Given this is a pilot study, we do not anticipate seeing a difference in our primary outcome of IFALD, but do anticipate some patients in the Smoflipid group will receive higher amount of calories and have greater rate of growth over time.
Description
Intravenous (or parenteral) nutrition is a necessary treatment for infants who cannot tolerate full feedings by mouth. The prolonged need for parenteral nutrition can lead to serious life threatening complications including liver damage, or intestinal failure associated liver disease (IFALD). Multiple strategies have been proposed to treat and prevent IFALD, but more information is still needed. Through this project we will compare two possible preventative treatment strategies including low does soy-lipid and a multi-component lipid, containing soy, MCT, olive, and fish oils (Smoflipid). This project will be a pilot study to better understand which (or both) strategies may benefit from further study in the future. Given this is a pilot study, we do not anticipate seeing a difference in our primary outcome of IFALD, but do anticipate some patients in the Smoflipid group will receive higher amount of calories and have greater rate of growth over time.
Details
| Condition | cholestasis |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8992 |
| Last Modified on | 19 February 2024 |
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