NCT02778698

Brief Summary

This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

First QC Date

May 18, 2016

Last Update Submit

March 8, 2019

Conditions

Cholestasis

Interventions

OmegavenDIETARY_SUPPLEMENT

Eligibility Criteria

Age15 Days - 5 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Male or female
  • Older than 14 days and less than 5 years of age
  • Direct bilirubin value is greater than 2 mg/dL
  • Be expected to require intravenous nutrition for at least an additional 28 days
  • Parent/legal guardian has agreed to provide consent/parental permission

You may not qualify if:

  • Patients who have a congenitally lethal condition (e.g. Trisomy 13).
  • Patients who have clinically severe bleeding not able to be managed with routine measures.
  • Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  • Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
  • The parent/legal guardian is unwilling to provide consent/parental permission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Edward A Everett, DO

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Last Updated

March 12, 2019

Record last verified: 2019-03