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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arthur J De Lorimier; University of California, Davis

Criteria

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