Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

Completed · Phase 1/Phase 2

Conditions studied: Parenteral Nutrition Associated Cholestasis

In brief

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Key facts

Study ID

NCT01601652

Run by

Arthur J De Lorimier

People needed

12

Starts

2011-11-01

Expected to finish

2018-12-01

Last updated by the study team

2021-01-27

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cholestasis defined as either
• serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
• serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis

You may not qualify if…

• Age > 1y at time that omegaven is started
• Not expected to survive at least 30 days
• Fish allergy in a first degree relative
• Hemodynamic instability
• Coagulopathy
• Not likely to require PN for > 30d
• Not expected to survive > 30d

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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