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NCT02721277 · ClinicalTrials.gov registry record · Phase 1
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02721277: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT02721277 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02721277, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often limits the growth capacity of parenteral nutrition-dependent infants. Inadequate growth is directly related to poor neurological outcomes, failure to facilitate mechanical ventilation, and less growth of the neonate's already damaged intestine. Ultimately, these outcomes can lead to severe disability and death. To mitigate these deleterious effects and optimize growth, parenteral nutrition-dependent infants with cholestasis who are not adequately growing on 1 g/kg/day of soy-based lipid emulsion must have a greater intake of lipids to meet their needs for weight, length, and head circumference growth. SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids. The utility of Omegaven and soy-based lipid emulsion is limited as these are restricted to 1 g/kg/day in cholestatic infants. SMOFlipid is safe to be provided at the usual goal infusion amount of 3 g/kg/day. Because this product includes both omega-6 and omega-3 lipids, it provides the benefits of the omega-3s for the liver and provides more than enough omega-6s to meet essential fatty acid requirements. Its use in situations in which growth is inadequate in babies who must be restricted to 1 g/kg/day can be expected to improve their growth and likely markedly increase their chances of both a good neurological outcome and survival. The aim of this research study is to dete
Primary Outcome
Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.
Interventions
- DRUG SMOFlipid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-02-02 |
| Phase | Phase 1 |
Why NCT02721277 stopped before completion
NCT02721277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which SMOFlipid is the first listed.
NCT02721277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02721277 about?
NCT02721277 is a clinical study titled "SMOFlipid to Lessen the Severity of Neonatal Cholestasis". Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function. In early PN-associated cholestasis, the dose of traditional soy based lipid is limited to 1 g/kg/day which often...
What is the current status of trial NCT02721277?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2016-05. Estimated completion is 2017-02-02.
What interventions are being tested in trial NCT02721277?
The interventions under investigation include: SMOFlipid (DRUG).
Who is sponsoring clinical trial NCT02721277?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02721277's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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