This expanded access protocol is for children that cannot get enough nutrients from food and must receive nutrition through a vein. The standard nutrition given through a vein is blend that has soybean fat. If this is given over a long period of time, it can cause problems. It can lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.
- : Omegaven
|Ages eligible for Study||up to 5 Years|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers|
- Male or female
- Older than 14 days and less than 5 years of age
- Direct bilirubin value is greater than 2 mg/dL
- Be expected to require intravenous nutrition for at least an additional 28 days
- Parent/legal guardian has agreed to provide consent/parental permission
- Patients who have a congenitally lethal condition (e.g. Trisomy 13).
- Patients who have clinically severe bleeding not able to be managed with routine measures.
- Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
- Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
- The parent/legal guardian is unwilling to provide consent/parental permission.
01 January, 0001
31 July, 2017