Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Study Details
Study Description
Brief Summary
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Drug: Omegaven |
Drug: Omegaven
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Other Names:
Drug: Omegaven
Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.
Drug: Omegaven
If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
|
Outcome Measures
Primary Outcome Measures
- Death associated with liver disease [Maximum 2 years]
Those patients with death only associated with liver diseasepre-treatment period and the expected rate of growth.
Secondary Outcome Measures
- Liver transplantation [Maximum 2 years]
- Growth over time as determined by weight in grams. [Maximum 2 years]
- Growth over time as measured by length in cm. [Maximum 2 years]
- Growth over time as measured by head circumference in cm. [Maximum 2 years]
- Development of essential fatty acid (EFA) deficiency as measured by triene:tetraene ratio in those with prolonged NPO status. [Maximum 2 years]
- Hyperlipidemia as measured by triglyceride level [Maximum 2 years]
Other Outcome Measures
- Culture positive bloodstream infection [Maximum 2 years]
Calculate the number (total and daily rate) of bloodstream infections prior to therapy, in each baby receiving Omegaven and compare with the previous rate.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
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Be expected to require intravenous nutrition for at least an additional 28 days
-
Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:
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Reduction of Intralipid® to 1 g/kg/day
-
Limiting trace minerals including copper and manganese
-
Initiation and use of Ursodiol
-
Cycling of parenteral nutrition
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Advancement of enteral feedings
- Parental informed consent must be signed.
Exclusion Criteria:
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Have a congenitally lethal condition (e.g. Trisomy 13).
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Have clinically severe bleeding not able to be managed with routine measures.
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Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
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Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
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Has culture positive sepsis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
Sponsors and Collaborators
- Mednax Center for Research, Education, Quality and Safety
Investigators
- Principal Investigator: Kaashif Ahmad, MD, Mednax Center for Research, Education, Quality and Safety
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WIRB Study# 1155515