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NCT03563222 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
A Phase 4 study, sponsored by Fresenius Kabi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03563222: Clinical Trial Phase 4 study, sponsored by Fresenius Kabi.
NCT03563222 is a Phase 4 study that was terminated before completion, run by Fresenius Kabi. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03563222, a Phase 4 study, was terminated before completion, sponsored by Fresenius Kabi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
Primary Outcome
Body weight of patients (patients \< 36 months of age)
Interventions
- DRUG Smoflipid
- DRUG Intralipid, 20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 4 |
Why NCT03563222 stopped before completion
NCT03563222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Smoflipid is the first listed.
NCT03563222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03563222 about?
NCT03563222 is a clinical study titled "Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age". Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
What is the current status of trial NCT03563222?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2019-12-18. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT03563222?
The interventions under investigation include: Smoflipid (DRUG), Intralipid, 20% (DRUG).
Who is sponsoring clinical trial NCT03563222?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03563222's enrollment target sits among peer trials
1 2000th of 2000 the lowest 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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