NCT02476994

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.

Conditions

• Essential Fatty Acid Deficiency (EFAD)

Interventions

Type	Name	Description
DRUG	Clinolipid
DRUG	Intralipid	Standard-of-Care Soybean Oil-Based Lipid Emulsion

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-06-22
• Last updated: 2021-07-21
• Results posted: 2017-12-05

Locations

4 sites across 1 country: United States