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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 is a NA study that was terminated before completion, run by OSF Healthcare System. The registered enrollment target is 19 participants.

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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.

Interventions

  • DRUG Intravenous Fat Emulsions

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2008-04
Est. Completion 2010-07
Phase NA

Sponsor

OSF Healthcare System

14 total trials

What the Registry Record Tells You About NCT01096446

The ClinicalTrials.gov registry entry for NCT01096446 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OSF Healthcare System, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intravenous Fat Emulsions is the first listed.

NCT01096446 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.