Phase 2
Completed N=12
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Parenteral Nutrition Associated Cholestasis
Source: ClinicalTrials.gov NCT01601652 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) — 2 mg/dl
Summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) |
2 | — |
| SECONDARY Liver Transaminases |
98 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01601652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.