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

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