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Sponsors and Collaborators: |
Baylor College of Medicine Children's Hospital Boston |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00738101 |
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
Condition | Intervention |
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Cholestasis Parenteral Nutrition |
Drug: Omegaven |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants |
Estimated Enrollment: | 15 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Drug: Omegaven
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Drug: Omegaven
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 months. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued up to a total of 5 months or whenever the infant no longer requires TPN.
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Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steve A Abrams, MD | 713-798-7124 | sabrams@bcm.edu |
Contact: Keli M Hawthorne, MS, RD | 713-798-7085 | kelih@bcm.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Keli M Hawthorne, MS, RD 713-798-7085 kelih@bcm.edu | |
Sub-Investigator: Beth A Carter, MD | |
Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Keli M Hawthorne, MS, RD 713-798-7085 kelih@bcm.edu | |
Sub-Investigator: Beth A Carter, MD |
Principal Investigator: | Steve A Abrams, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Steven A. Abrams, MD ) |
Study ID Numbers: | H-23365 |
Study First Received: | August 18, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00738101 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Bile Duct Diseases Cholestasis Biliary Tract Diseases Bilirubin |