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Intravenous Fat Emulsions and Premature Infants

NCT01096446 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-11-20

Study results available
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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.

Conditions

Interventions

DRUG

Intravenous Fat Emulsions

Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day

Sponsors & Collaborators

  • OSF Healthcare System

    lead OTHER

Principal Investigators

  • Kamlesh S Macwan, MD · University of Illinois College of Medicine at Peoria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096446 on ClinicalTrials.gov