NCT04555044

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

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 (Part A)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 0 Years – 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 (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric population.

Conditions

• Essential Fatty Acid Deficiency (EFAD)

Interventions

Type	Name	Description
DRUG	Clinolipid	Lipid injectable emulsion, USP 20%
DRUG	Intralipid	Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-10-16
• Completion: 2022-11-16
• First posted: 2020-09-18
• Last updated: 2023-12-27
• Results posted: 2023-12-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study