SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Cholestasis, Jaundice, Obstructive
About this trial
This is an interventional supportive care trial for Cholestasis focused on measuring Parenteral nutrition, Total, Infant, newborn, Cholestasis, Enterocolitis, Necrotizing
Eligibility Criteria
Inclusion Criteria:
- Greater than 14 days old and less than 1 year of age.
- Greater than 1 kg.
- Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL
- Currently standard therapy with soy-based Intralipid
- Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
- Be expected to require intravenous nutrition for at least an additional 21 days
Exclusion Criteria:
- Have a congenitally lethal condition.
- Have clinically severe bleeding or clinical liver failure 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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Experimental
SMOFlipid
Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.