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Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
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.
Details
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 293 |
| Start date | 2008-09 |
| Completion | 2020-03-27 |
Conditions
- Cholestasis
- Cholestasis of Parenteral Nutrition
Interventions
- Omegaven
Primary outcomes
- Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study — From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years).
Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin≤ 2 mg/dL prior to EOS (end of study). - All Cause Mortality During the Study. — From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years).
To describe proportion of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion. - Growth Z-scores for Weight — From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years).
The Z-score indicated the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean. A weight Z-score of ≤ -2 indicates an underweight status, while a weight Z-score of ≥ 2 indicates overweight or obese status.
Countries
United States