Status:
COMPLETED
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Parenteral Nutrition Associated Liver Disease
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE4
Brief Summary
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soy...
Detailed Description
Babies in the newborn intensive care unit with evidence of liver damage from Total Parenteral Nutrition (TPN), as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at l...
Eligibility Criteria
Inclusion
- Infants in the newborn intensive care unit
- TPN cholestasis of at least 2.5 mg/dl
- Anticipated TPN treatment for at least one month
- signed informed consent
Exclusion
- Enrollment in another trial
- Lack of consent
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00862446
Start Date
March 1 2009
End Date
October 1 2019
Last Update
January 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Monroe Carell Jr Children's Hospital at vanderbilt
Nashville, Tennessee, United States, 37232