Phase 4
N=48
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition Associated Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT00862446 ↗Enrolled (actual)
48
Serious AEs
10.4%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Resolution of the Direct Hyperbilirubinemia — 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omegaven (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Resolution of the Direct Hyperbilirubinemia |
29 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00862446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.