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

Essential Fatty Acid Deficiency (EFAD) Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Essential Fatty Acid Deficiency (EFAD)

• NCT number: NCT04555044
• Study type: Interventional
• Source: Baxter Healthcare Corporation
• Status: Completed
• Phase: Phase 4
• Start date: January 22, 2021
• Completion date: November 16, 2022