We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00702767
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : June 24, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study was completed in October 2006. No further participates are being recruited.

Condition or disease Intervention/treatment
Low Birth Weight Drug: INTRALIPIDS

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life
Study Start Date : July 2005
Primary Completion Date : October 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: INTRALIPIDS
    INTRAVENOUS FAT EMULSIONS

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kamlesh S. Macwan, Neonatalogist, Children's Hospital of Illinois at OSF-Saint Francis Medical Center
ClinicalTrials.gov Identifier: NCT00702767     History of Changes
Obsolete Identifiers: NCT00516997
Other Study ID Numbers: 05-060
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008

Keywords provided by OSF Healthcare System:
This study was completed in October 2006

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions