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Trial record 12 of 156 for:    Recruiting, Not yet recruiting, Available Studies | parenteral nutrition

Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury (Omegaven)

This study is currently recruiting participants.
Verified December 2016 by The University of Texas Health Science Center at San Antonio
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425567
First Posted: August 30, 2011
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
If a child is unable to tolerate enough of his/her feeding orally to grow and requires that nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease. This is called cholestasis. IV fat that children receive may be contributing to this liver disease. A different fat mixture comprised from fish oil could be used in place of intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We believe the use of fish oil may provide less liver disease and decrease the need of liver transplant or dying than those who receive the usual fat.

Condition Intervention
Liver Disease Drug: Intravenous Lipid Emulsion Comprised of Fish Oil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • death associated to liver disease [ Time Frame: 1 year ]
    Death only associated to liver disease


Secondary Outcome Measures:
  • Liver transplant [ Time Frame: 1 year ]
    Liver transplant secondary to parenteral nutrition associated liver disease


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven Intravenously
Infants in this arm have PNALD with direct bilirubin >4 mg/dL
Drug: Intravenous Lipid Emulsion Comprised of Fish Oil
IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
Other Name: Omegaven
Experimental: Omegaven Intravenously for PNALD High Risk Patients
Infants in this arm are at HIGH Risk of developing PNALD and have direct bilirubin >1mg/dL but less than 4 mg/dL.
Drug: Intravenous Lipid Emulsion Comprised of Fish Oil
IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
Other Name: Omegaven

Detailed Description:
If a child is unable to tolerate enough of his/her feeding orally to grow and requires that nutrition is given by vein (IV parenteral nutrition), it can result in severe liver disease. This is called cholestasis. IV fat that children receive may be contributing to this liver disease. A different fat mixture comprised from fish oil could be used in place of intralipid. This is a compassionate use of the fish oil and not a comparison of the two. We believe the use of fish oil may improve liver disease and decrease the need of liver transplant or dying than those who receive the usual fat. The rest of the IV nutrition is as per standard of care
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 * If infants qualify for high risk ARM (gastroschisis, ileal atresia, <750 grams and stage III NEC) d bilirubin >1 mg/dL but less than 4 mg/dL.

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

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01425567


Locations
United States, Texas
University Health System Recruiting
San Antonio, Texas, United States, 78229
Contact: Laurie Weaver, RN    210-358-1593    laurie.weaver@uhs-sa.com   
Principal Investigator: Cynthia Blanco, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Cynthia Blanco, MD University of Texas
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01425567     History of Changes
Other Study ID Numbers: HSC2011-0211T
First Submitted: August 3, 2011
First Posted: August 30, 2011
Last Update Posted: January 11, 2017
Last Verified: December 2016

Keywords provided by The University of Texas Health Science Center at San Antonio:
cholestasis
parenteral nutrition

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions