ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00862446
Recruitment Status : Recruiting
First Posted : March 17, 2009
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 soybean oil. There is a suggestion in the literature that using fishoil based fats called omega-3 fat emulsions can decrease or even reverse this liver damage. We will offer babies with evidence of liver damage and no ability to eat,the Omegaven and see if the liver damage reverses.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Associated Liver Disease Drug: Omegaven Phase 4

Detailed Description:
Babies in the newborn intensive care unit with evidence of liver damage from TPN, as indicated by a direct bilirubin of greater than 2.5 , and who will not be fed for at least another month will be offered the trial. they will be changed from the intralipid to Omegaven as the source of their fat. We will continue routine monitoring of their nutrition and liver function.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Study Start Date : March 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment
All infants will receive Omegaven
 Drug: Omegaven
1 gram/kg/day daily until on feeds


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Resolution of the direct hyperbilirubinemia [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Enrollment in another trial
  • Lack of consent
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862446


Locations
United States, Tennessee
Monroe Carell Jr Children's Hospital at vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: William F Walsh, MD    615-322-0545    bill.walsh@vanderbilt.edu   
Principal Investigator: William F Walsh, MD         
Sponsors and Collaborators
Vanderbilt University
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: William Walsh, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00862446     History of Changes
Other Study ID Numbers: 080887
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by William Walsh, Vanderbilt University:
Parenteral nutrition associate liver disease
TPN cholestasis
TPN Associated Liver Disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases