Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
Conditions
Brief summary
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard soybean oil based intravenous lipid emulsion (Intralipid) versus a fish-oil based lipid emulsion (Omegaven) in infants with severe cholestasis.
Detailed description
Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises \>100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).
Interventions
DIETARY_SUPPLEMENTOmegaven
Omegaven 1g/kg/day until infant receiving full enteral feeds
DIETARY_SUPPLEMENTLipid minimization
1g/kg/day daily until infant receiving full enteral feeds IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)
Sponsors
Child and Family Research Institute
Children's & Women's Health Centre of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* infants admitted to neonatal intensive care unit * severe cholestasis, defined as conjugated bilirubin greater than 35 * receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days * signed consent
Exclusion criteria
* hepatitis (TORCH or other viral infection) * primary liver disease as etiology of cholestasis * clinically severe bleeding not able to be managed with routine measures * lethal congenital abnormalities * congenital heart disease associated with right heart dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | up to 1 year | Success of the pilot trial will be determined by reaching the following criteria: 98.5% of subjects receive the modified lipid therapy within 12 to 24h of randomization; and/or 90% of subjects had their labs taken at the appropriate times as detailed by the study protocol. |
| Clinical endpoint | up to 1 year | The proportion of subjects in each group that have a rise in conjugated bilirubin to or over 100 after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Total duration of parenteral nutrition | up to 1 year |
| Growth | up to 1 year |
Countries
Canada
Outcome results
None listed