Liver Disease
Conditions
Keywords
cholestasis, parenteral nutrition
Brief summary
To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.
Detailed description
Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).
Interventions
DRUGIntravenous Lipid Emulsion Comprised of Fish Oil
IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
Sponsors
The University of Texas Health Science Center at San Antonio
Eligibility
Sex/Gender
ALL
Age
14 Days to 24 Months
Healthy volunteers
No
Inclusion criteria
: \- \>14 days \<24 months\* Anatomic short gut (\< 50 % bowel removed) with total bilirubin \> or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin \> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days \* Patients with direct bilirubin \> or = 6 mg/dL who do not meet criteria above but meet criteria with \* If infants qualify for high risk ARM (gastroschisis, ileal atresia, \<750 grams and stage III NEC) d bilirubin \>1 mg/dL but less than 4 mg/dL.
Exclusion criteria
Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish
Countries
United States
Outcome results
None listed