A Phase 4 interventional study of Omegaven in Parenteral Nutrition Associated Liver Disease, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All infants will receive Omegaven
Drug: Omegaven
1 gram/kg/day daily until on feeds
Number of Participants With Resolution of the Direct Hyperbilirubinemia
Defined as direct bilirubin \<2.0 mg/dL
Time frame: At discharge or up to 10 weeks
| Milestone | Omegaven Treatment |
|---|---|
| Started | 48 |
| Completed | 48 |
| Not completed | 0 |
Defined as direct bilirubin \<2.0 mg/dL
| Participants | Omegaven Treatment |
|---|---|
| Number of Participants With Resolution of the Direct Hyperbilirubinemia | 29 |
Collected over Baseline to Week 10. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omegaven Treatment | 6/48 (12.5%) | 5/48 (10.4%) | 0/48 (0%) |
| Event | Omegaven Treatment |
|---|---|
| HypertriglyceridemiaBlood and lymphatic system disorders | 5/48 |
| CoagulopathyBlood and lymphatic system disorders | 1/48 |
| Age, Continuous(days) | Omegaven Treatment |
|---|---|
| Mean | 63.875 ± 32.25 |
| Sex: Female, Male(Participants) | Omegaven Treatment |
|---|---|
| Female | 22 |
| Male | 26 |
| Race and Ethnicity Not Collected(Participants) | Omegaven Treatment |
|---|
| Region of Enrollment(participants) | Omegaven Treatment |
|---|---|
| United States | 48 |
| Direct Bilirubin(mg/dL) | Omegaven Treatment |
|---|---|
| Mean | 6.25 ± 3.83 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center