Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
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ClinicalTrials.gov Identifier: NCT00862446 |
Recruitment Status
:
Recruiting
First Posted
: March 17, 2009
Last Update Posted
: February 14, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parenteral Nutrition Associated Liver Disease | Drug: Omegaven | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease |
Study Start Date : | March 2009 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
All infants will receive Omegaven
|
Drug: Omegaven
1 gram/kg/day daily until on feeds
|
- Resolution of the direct hyperbilirubinemia [ Time Frame: 3 months ]

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Ages Eligible for Study: | up to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862446
United States, Tennessee | |
Monroe Carell Jr Children's Hospital at vanderbilt | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: William F Walsh, MD 615-322-0545 bill.walsh@vanderbilt.edu | |
Principal Investigator: William F Walsh, MD |
Responsible Party: | William Walsh, Professor of Pediatrics, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00862446 History of Changes |
Other Study ID Numbers: |
080887 |
First Posted: | March 17, 2009 Key Record Dates |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Keywords provided by William Walsh, Vanderbilt University:
Parenteral nutrition associate liver disease TPN cholestasis TPN Associated Liver Disease |
Additional relevant MeSH terms:
Liver Diseases Digestive System Diseases |