Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants

This study has been completed.

Sponsor:

Information provided by:

OSF Healthcare System

ClinicalTrials.gov Identifier:

NCT00702767

First received: June 19, 2008

Last updated: June 23, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 19, 2008
Last Updated Date	June 23, 2008
Start Date ^ICMJE	July 2005
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00702767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants
Official Title ^ICMJE	Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life
Brief Summary	This study was completed in October 2006. No further participates are being recruited.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Low Birth Weight
Intervention ^ICMJE	Drug: INTRALIPIDS INTRAVENOUS FAT EMULSIONS
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	110
Completion Date	April 2007
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 1 Day
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00702767
Other Study ID Numbers ^ICMJE	05-060
Has Data Monitoring Committee	No
Responsible Party	Dr. Kamlesh S. Macwan, Neonatalogist, Children's Hospital of Illinois at OSF-Saint Francis Medical Center
Study Sponsor ^ICMJE	OSF Healthcare System
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	OSF Healthcare System
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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