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



Status:Enrolling by invitation
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 1
Updated:4/17/2018
Start Date:November 2011
End Date:November 2021

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Trial Summary
Trial Overview
Inclusion Criteria

Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

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


Inclusion Criteria:

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

Exclusion Criteria:

- 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
We found this trial at
1
site
University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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mi
from
Sacramento, CA
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