Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholestasis

Clinical Trial Details

NCT number	NCT02357576
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	Phase 3
Start date	May 21, 2016
Completion date	November 8, 2019

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