NCT02357576

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

Phase 3 Study of Standard Lipid Therapy Versus Intravenous Fat Emulsion Minimization for the Prevention of Parenteral Nutrition-Associated Liver Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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

Conditions

• Cholestasis

Interventions

Type	Name	Description
DRUG	Intralipid 20% I.V. Fat Emulsion

Timeline

• Start date: 2016-05-21
• Primary completion: 2017-10-12
• Completion: 2019-11-08
• First posted: 2015-02-06
• Last updated: 2020-12-17
• Results posted: 2020-01-23

Locations

5 sites across 1 country: United States