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

Arthur J De Lorimier

Status and phase: Completed; Phase 2; Phase 1

Conditions: Parenteral Nutrition Associated Cholestasis

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT01601652

UCD#225576-3 (Other Identifier)

225576

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Omeagven

Experimental group

Treatment:

Drug: Omegaven