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NCT01096446 · ClinicalTrials.gov registry record · NA
Intravenous Fat Emulsions and Premature Infants
A NA study, sponsored by OSF Healthcare System.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT01096446: Clinical Trial NA study, sponsored by OSF Healthcare System.
NCT01096446 is a NA study that was terminated before completion, run by OSF Healthcare System. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096446, a NA study, was terminated before completion, sponsored by OSF Healthcare System.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who are born at less than 750 grams who are started at a higher infusion rate of intravenous lipid emulsions (2 gm/kg/day). These infants will be compared with a control group who are at the standard lipid emulsion infusion rate (0.5 gm/kg/day). hypothesis: A. Objectives of this project. Null Hypothesis: There will not be a significant difference for Extremely Low Birth Weight Infants (ELBW) \<750 grams being able to tolerate a higher infusion rate of Intravenous Fat Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by maintenance of a serum triglyceride level of 200 mg/dl or less. Alternative Hypothesis: There will be a significant difference (p\<0.05) for Extremely Low Birth Weight Infants (ELBW) \<750 grams being able to tolerate a higher infusion rate of Intravenous Fat Emulsions (IVFE) within the first days of life (days 1-7) as evidenced by maintenance of a serum triglyceride level of 200 mg/dl or less.
Primary Outcome
Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.
Interventions
- DRUG Intravenous Fat Emulsions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-07 |
| Phase | NA |
Why NCT01096446 stopped before completion
NCT01096446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravenous Fat Emulsions is the first listed.
NCT01096446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096446 about?
NCT01096446 is a clinical study titled "Intravenous Fat Emulsions and Premature Infants". The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who are born at less than 750 grams who are started at a higher infusion rate of intravenous lipid emulsions (2 gm/kg/day). These infants will be compared with a control group who are at the standard lipid emul...
What is the current status of trial NCT01096446?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2008-04. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01096446?
The interventions under investigation include: Intravenous Fat Emulsions (DRUG).
Who is sponsoring clinical trial NCT01096446?
This trial is sponsored by OSF Healthcare System, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01096446's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 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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