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

NCT04555044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-12-27

Study results available
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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

DRUG

Clinolipid

Lipid injectable emulsion, USP 20%

DRUG

Intralipid

Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Baxter Healthcare Corporation · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2022-10-16
Completion
2022-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555044 on ClinicalTrials.gov