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 June 2015 by Vanderbilt University

Sponsor:

Information provided by (Responsible Party):

William Walsh, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00862446

First received: March 13, 2009

Last updated: June 1, 2015

Last verified: June 2015

History of Changes

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:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Parenteral Nutrition, Total

U.S. FDA Resources

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 (Child)
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


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:	June 1, 2015
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 September 26, 2016

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