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NCT04555044 · ClinicalTrials.gov registry record · Phase 4
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
A Phase 4 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT04555044: Completed Phase 4 study, sponsored by Baxter Healthcare Corporation.
NCT04555044 is a Phase 4 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 101 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04555044, a Phase 4 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid \[mead acid\] to 5,8,11,14 eicosatetraenoic acid \[arachidonic acid, \[ARA\] ratio
Interventions
- DRUG Intralipid
- DRUG Clinolipid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 4 |
What the finished NCT04555044 record still lists
NCT04555044 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Intralipid is the first listed.
NCT04555044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04555044 about?
NCT04555044 is a clinical study titled "Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)". 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 safet...
What is the current status of trial NCT04555044?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2021-01-22. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT04555044?
The interventions under investigation include: Intralipid (DRUG), Clinolipid (DRUG).
Who is sponsoring clinical trial NCT04555044?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04555044's enrollment target sits among peer trials
101 766th of 2000 higher than 1,231 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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