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

Parenteral Nutrition Associated Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862446
• Other study ID #: 080887
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: October 2019

Study information

• Verified date: December 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 fish oil 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition Associated Liver Disease

Intervention

Drug:
• Omegaven
1 gram/kg/day daily until on feeds

Locations

Country	Name	City	State
United States	Monroe Carell Jr Children's Hospital at vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Resolution of the Direct Hyperbilirubinemia	Defined as direct bilirubin <2.0 mg/dL	At discharge or up to 10 weeks