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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All infants will receive Omegaven |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven | Drug | 1 gram/kg/day daily until on feeds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resolution of the Direct Hyperbilirubinemia | Defined as direct bilirubin <2.0 mg/dL | At discharge or up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr Children's Hospital at vanderbilt | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omegaven Treatment | All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omegaven Treatment | All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Resolution of the Direct Hyperbilirubinemia | Defined as direct bilirubin <2.0 mg/dL | Posted | Count of Participants | Participants | At discharge or up to 10 weeks |
|
|
Baseline to Week 10
The only adverse collected were mortality, coagulopathy, hypertriglyceridemia
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omegaven Treatment | All participants received Omegaven: 1 gram/kg/day daily until they were able to ingest adequate nutrition enterally |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment | Prolonged or excessive bleeding |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Walsh | Vanderbilt University Medical Center | 615-322-3476 | bill.walsh@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2010 | Nov 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
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| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Direct Bilirubin | Mean | Standard Deviation | mg/dL |
|
|
| 6 |
| 48 |
| 5 |
| 48 |
| 0 |
| 48 |
|
| Hypertriglyceridemia | Blood and lymphatic system disorders | Systematic Assessment |
|
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