APPROVED_FOR_MARKETINGNot Applicable

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

United States

Plain-language 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.

Who can participate

Age range14 Days – 2 Years

SexALL

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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.
✓. 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:
✓. Parental informed consent must be signed.

Exclusion criteria

✕. Have a congenitally lethal condition (e.g. Trisomy 13).
✕. Have clinically severe bleeding not able to be managed with routine measures.
✕. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
✕. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
✕. Has culture positive sepsis

Trial details

NCT IDNCT02534077

SponsorPediatrix

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Total Parenteral Nutrition-induced Cholestasis trials