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

Phase 4

Completed

• Conditions: Parenteral Nutrition Associated Liver Disease
• Interventions: Drug: Omegaven

• Registration Number: NCT00862446
• Lead Sponsor: Vanderbilt University Medical Center

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 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.

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 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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Results First Submitted: 2020-11-17
• Results First Submitted QC: 2020-11-17
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Results First Posted: 2020-12-14
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Omegaven	All infants will receive Omegaven

Primary Outcome Measures

Name	Time	Method
Number of Participants With Resolution of the Direct Hyperbilirubinemia	At discharge or up to 10 weeks	Defined as direct bilirubin \<2.0 mg/dL

Trial Locations

Locations (1)

Monroe Carell Jr Children's Hospital at vanderbilt; 🇺🇸 Nashville, Tennessee, United States