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

Eligibility

Eligible Ages
Under 24 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment
All infants will receive Omegaven
  • Drug: Omegaven
    1 gram/kg/day daily until on feeds

Recruiting Locations

Monroe Carell Jr Children's Hospital at vanderbilt
Nashville, Tennessee 37232
Contact:
William F Walsh, MD
615-322-0545
bill.walsh@vanderbilt.edu

More Details

NCT ID
NCT00862446
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.