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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Parenteral Nutrition Associated Cholestasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omeagven

Group Type EXPERIMENTAL

Omegaven

Intervention Type DRUG

1 g/kg/d iv infusion over 24h

Interventions

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Omegaven

1 g/kg/d iv infusion over 24h

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No