Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCD#225576-3 | Other Identifier | UC Davis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeagven | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven | Drug | 1 g/kg/d iv infusion over 24h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) | approximately for 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Transaminases | approximately for 4 months |
Not provided
Inclusion Criteria:
Cholestasis defined as either
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian J Griffin, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
Not provided
Started Omegaven: N=12
1 Died of complications not related to omegavin 5 Weaned off PN before DC (2F, 3M) 6 Discharged Home on PN (of these 3 remain on PN[all male]; 3 weaned off after DC [2M, 1F])
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Omeagven | Omegaven: 1 g/kg/d iv infusion over 24h |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
12 started omegaven
1 Died M 5 weaned off PN in NICU (2F, 3M) 6 DC home on PN (3M continue on PN; 2M &1F weaned off )
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omeagven | Omegaven: 1 g/kg/d iv infusion over 24h |
| 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 | Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) | Posted | Mean | Standard Deviation | mg/dl | approximately for 4 months |
|
|
36 mo
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omeagven | Omegaven: 1 g/kg/d iv infusion over 24h | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypertriglyceridemia | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur J de Lorimier, Director of Pediatric Gastroenterology | UC Davis | 916-734-3112 | adelorimier@ucdavis.edu |
Not provided
| 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 | Jan 12, 2018 | Nov 17, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2018 | Nov 17, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| month |
|
| 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 |
|
|
| Secondary | Liver Transaminases | Posted | Mean | Standard Deviation | mg/dl | approximately for 4 months |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided
Not provided