Compassionate Use of Omegaven
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.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02778698
|Contact: Edward A Everett, DOemail@example.com|
|Contact: Anne Russo, MDfirstname.lastname@example.org|
|Principal Investigator:||Edward A Everett, DO||Geisinger Clinic|