Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Status:
Completed
Trial end date:
2019-11-08
Target enrollment:
Participant gender:
Summary
Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated
with significant morbidity and mortality in neonates and is felt to be exacerbated by
soybean-based lipid emulsions. Much research is currently being directed at identifying ways
to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of
parenteral nutrition is one possible strategy. In this study we will compare standard dosing
of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for
the development of cholestasis and adequate growth between the two groups. Longterm followup
will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.
Funding source - FDA OOPD
Phase:
Phase 3
Details
Lead Sponsor:
University of Michigan
Collaborators:
Primary Children's Hospital Seattle Children's Hospital University of Colorado, Denver University of Florida