|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01425567 |
|
Date of registration:
|
03/08/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
Omegaven |
|
Scientific title:
|
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children |
|
Date of first enrolment:
|
August 2011 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01425567 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Laurie Weaver, RN |
|
Address:
|
|
|
Telephone:
|
210-358-1593 |
|
Email:
|
laurie.weaver@uhs-sa.com |
|
Affiliation:
|
|
|
|
Name:
|
Cynthia Blanco, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Texas |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- >14 days <24 months* Anatomic short gut (< 50 % bowel removed) with total bilirubin > or
= 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin
> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV
nutrition an additional 28 days * Patients with direct bilirubin > or = 6 mg/dL who do not
meet criteria above but meet criteria with *
Exclusion Criteria:
Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral
hepatitis or primary liver disease as etiology of their cholestasis Other health problems
such as survival extremely unlikely even if cholestasis improves Known allergies to eggs
or shellfish
Age minimum:
N/A
Age maximum:
24 Months
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Liver Disease
|
|
Intervention(s)
|
|
Drug: Intravenous Lipid Emulsion Comprised of Fish Oil
|
|
Primary Outcome(s)
|
|
death associated to liver disease
[Time Frame: duration of hospital stay up to 1 year]
|
|
Secondary Outcome(s)
|
|
Liver transplant
[Time Frame: duration of hospital stay up to 1 year]
|
|
Secondary ID(s)
|
|
HSC2011-0211T
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|