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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00862446
First received: March 13, 2009
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Parenteral Nutrition Associated Liver Disease
Drug: Omegaven
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Resolution of the direct hyperbilirubinemia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
All infants will receive Omegaven
Drug: Omegaven
1 gram/kg/day daily until on feeds

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: William Walsh, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00862446     History of Changes
Other Study ID Numbers: 080887
Study First Received: March 13, 2009
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014