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

NCT00862446 | Completed Phase 4 Results DMC

• 1 other identifier: 080887
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenteral Nutrition Associated Liver Disease

Keywords

Parenteral nutrition associate liver disease; TPN cholestasis; TPN Associated Liver Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Resolution of the Direct Hyperbilirubinemia

  Defined as direct bilirubin \<2.0 mg/dL

  At discharge or up to 10 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

All infants will receive Omegaven

Drug: Omegaven

Interventions

Omegaven DRUG

1 gram/kg/day daily until on feeds

Treatment

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Enrollment in another trial
• Lack of consent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Monroe Carell Jr Children's Hospital at vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

fish oil triglycerides

Results Point of Contact

• Title: William Walsh
• Organization: Vanderbilt University Medical Center

bill.walsh@vumc.org

615-322-3476

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 17, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 5, 2021
• Results First Posted: December 14, 2020

Record last verified: 2020-12

Locations

US (1)