Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
- Registration Number
- NCT01601652
- Lead Sponsor
- Arthur J De Lorimier
- Brief Summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Omeagven Omegaven -
- Primary Outcome Measures
Name Time Method Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) approximately for 4 months
- Secondary Outcome Measures
Name Time Method Liver Transaminases approximately for 4 months
Trial Locations
- Locations (1)
University of California Davis Medical Center
🇺🇸Sacramento, California, United States