NCT01425567

Brief Summary

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

First QC Date

August 3, 2011

Last Update Submit

February 11, 2019

Conditions

Liver Disease

Keywords

cholestasisparenteral nutrition

Interventions

Intravenous Lipid Emulsion Comprised of Fish OilDRUG

IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease

Also known as: Omegaven

Eligibility Criteria

Age14 Days - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- \>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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health System

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Sorrell M, Moreira A, Green K, Jacob R, Tragus R, Keller L, Quinn A, McCurnin D, Gong A, El Sakka A, Mittal N, Blanco C. Favorable Outcomes of Preterm Infants With Parenteral Nutrition-associated Liver Disease Treated With Intravenous Fish Oil-based Lipid Emulsion. J Pediatr Gastroenterol Nutr. 2017 May;64(5):783-788. doi: 10.1097/MPG.0000000000001397.

    PMID: 28437326DERIVED

MeSH Terms

Conditions

Liver DiseasesCholestasisHyperphagia

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Digestive System DiseasesBile Duct DiseasesBiliary Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Blanco, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 30, 2011

Last Updated

February 12, 2019

Record last verified: 2019-01

Locations

US(1)