Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
Public ClinicalTrials.gov record NCT04555044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04555044
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 22, 2021 (Actual)
- Primary completion
- Oct 16, 2022 (Actual)
- Completion
- Nov 16, 2022 (Actual)
- Last update posted
- Dec 27, 2023
2021 – 2022
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baxter Investigational Site | Mobile | Alabama | 36604 | — |
| Baxter Investigational Site | New Haven | Connecticut | 06520 | — |
| Baxter Investigational Site | Orlando | Florida | 32803 | — |
| Baxter Investigational Site | Boston | Massachusetts | 09111 | — |
| Baxter Investigational Site | Jackson | Mississippi | 39216 | — |
| Baxter Investigational Site | Greenville | North Carolina | 27834 | — |
| Baxter Investigational Site | Memphis | Tennessee | 38163 | — |
| Baxter Investigational Site | San Antonio | Texas | 78229 | — |
| Baxter Investigational Site | Provo | Utah | 84604 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04555044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 27, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04555044 live on ClinicalTrials.gov.