Back to resultsTolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants
Primary Purpose
Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INTRALIPIDS
Sponsored by
About this trial
This is an interventional treatment trial for Low Birth Weight focused on measuring This study was completed in October 2006
Eligibility Criteria
Inclusion Criteria:
- All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00702767
Brief Title
Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants
Official Title
Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
OSF Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was completed in October 2006. No further participates are being recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight
Keywords
This study was completed in October 2006
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
INTRALIPIDS
Intervention Description
INTRAVENOUS FAT EMULSIONS
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.
12. IPD Sharing Statement
Citations:
PubMed Identifier
18829797
Citation
Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.
Results Reference
derived
Learn more about this trial
Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants
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