Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral
Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to
prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of
standard intravenous fat emulsions have implicated in the development and progression of
PNAC.
In this study, neonates with congenital/acquired gastrointestinal disorders will be
randomized, in a unblinded fashion, to receive either the standard dose of an intravenous
omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion
throughout their course of PN or until hospital discharge, death or 100 days of life,
whichever comes first. The primary outcome will be the presence of cholestasis.