Parenteral Nutrition Associated Liver Disease
Conditions
Keywords
Parenteral nutrition associate liver disease, TPN cholestasis, TPN Associated Liver Disease
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.
Interventions
DRUGOmegaven
1 gram/kg/day daily until on feeds
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of the Direct Hyperbilirubinemia | At discharge or up to 10 weeks | Defined as direct bilirubin \<2.0 mg/dL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omegaven Treatment All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Omegaven Treatment | — |
|---|---|---|
| Age, Continuous | 63.875 days STANDARD_DEVIATION 32.25 | — |
| Direct Bilirubin | 6.25 mg/dL STANDARD_DEVIATION 3.83 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 48 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 5 / 48 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omegaven Treatment | Number of Participants With Resolution of the Direct Hyperbilirubinemia | 29 Participants |