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NCT00278928 · ClinicalTrials.gov registry record · NA
Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic
A NA study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT00278928: Clinical Trial NA study, sponsored by Beth Israel Deaconess Medical Center.
NCT00278928 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 82 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00278928, a NA study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study Summary
This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid injectable emulsions are an essential nutrient for neonatal growth and development. Traditionally, lipid injectable emulsions have been commercially available in sterile glass bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions stored in glass bottles versus those in plastic, significant differences were noted in the population of large-diameter fat globules by globule size analysis, reflective of a less stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has proposed to limit this large diameter fat globule population to a volume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid concentration. (At the present time, the USP monograph is not officially recognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate 55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal number of products packaged in plastic. We hypothesize this difference may explain the recent clinical observations. We will compare the incidence of hypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic. The study will attempt to discern whether the differences in packaging influence the stability and subsequent tolerance of lipid injectable emulsions.
Interventions
- DRUG Liposyn III 20% (lipid infusion)
- DRUG Intralipid 20% (lipid infusion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-04 |
| Phase | NA |
Why NCT00278928 stopped before completion
NCT00278928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Liposyn III 20% (lipid infusion) is the first listed.
NCT00278928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00278928 about?
NCT00278928 is a clinical study titled "Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic". This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid injectable emulsions are an essential nutrient for neonatal growth and development. Traditionally, lipid injectable emulsion...
What is the current status of trial NCT00278928?
This trial is currently terminated. It is a NA study. The enrollment target is 82 participants. The study started on 2006-01. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00278928?
The interventions under investigation include: Liposyn III 20% (lipid infusion) (DRUG), Intralipid 20% (lipid infusion) (DRUG).
Who is sponsoring clinical trial NCT00278928?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00278928's enrollment target sits among peer trials
82 990th of 2000 higher than 1,009 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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