Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
63 participants
INTERVENTIONAL
2015-06-30
2019-09-27
Brief Summary
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Detailed Description
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Up to 200 children will be eligible for enrollment.
Direct bilirubin levels and other labs will be monitored as well as growth parameters.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Omegaven
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
Omegaven
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.
Interventions
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Omegaven
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age less than 18 years, both sexes, all races
* Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
* Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
* Are not currently enrolled in another lipid emulsion study
Exclusion Criteria
* Known metabolic disorder of lipid metabolism
* Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
* Medical condition likely to result in death in the next 30 days
18 Years
ALL
No
Sponsors
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OU Medical Center
UNKNOWN
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Kimberly D Ernst, MD, MSMI
Role: PRINCIPAL_INVESTIGATOR
The University of Oklahoma, Department of Pediatrics
Locations
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OU Children's Hospital
Oklahoma City, Oklahoma, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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5451
Identifier Type: -
Identifier Source: org_study_id
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