Increase Infusion Rates of Intravenous Fat Emulsions - Full Text View

Purpose

The purpose of this study to evaluate the tolerance of providing very low birth weight infants increased infusion rates of intravenous fat emulsions (IVFE) in their total parenteral nutrition solutions during the first week of life.

The hypothesis was as follows: Very Low Birth Weight Infants (VLBW) between 750 grams to 1500 grams will tolerate a higher infusion rate of 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.

Condition	Intervention
Hypertriglyceridemia Hyperglycemia	Other: fat emulsions

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Diabetes Medicines Hyperglycemia Triglycerides

Drug Information available for: Liposyn II Liposyn III

U.S. FDA Resources

Further study details as provided by OSF Healthcare System:

Primary Outcome Measures:

To evaluate the tolerance of VLBW infants to receiving higher than standard infusion rates of Intralipid emulsion during the first week of life. Triglycerides (200 gm/dl or less) [ Time Frame: For 7 days after starting parenteral nutrition ]

Secondary Outcome Measures:

To achieve meeting estimated nutritional needs of VLBW infants for total parenteral nutrition (TPN) of 90 calories/kg/day within the first week of life. [ Time Frame: 7 days after starting parenteral nutrition ]
To achieve a return to birth weight for VLBW infants significantly sooner. [ Time Frame: Two weeks after birth ]
To maintain blood sugar levels of VLBW infants at less than 200mg/dl. [ Time Frame: 7 days after starting parenteral nutrition ]

Enrollment:	110
Study Start Date:	June 2005
Study Completion Date:	February 2007

Arms	Assigned Interventions
Experimental: High Lipids Infants in the experimental group received 2 grams/kilogram/day (gm/kg/d) of IVFE in their parenteral nutrition solution.	Other: fat emulsions Intravenous Fat Emulsions were increased by 0.5 grams/kg/day daily until goal 3 gm/kg/d
No Intervention: Low Lipids IVFE were started at 0.5 gm/kg/day in parenteral nutrition.	Other: fat emulsions IVFE were increased daily by 05 gm/kg/d until goal of 3 gm/kg/d

Detailed Description:

After inform consent was obtains from parents a sealed envelope was opened to reveal which study group they were allocated to. The experimental group (High Lipids) were started at 2 gm/kg/d of IVFE in the parenteral nutrition solution. The control group (Low Lipids) were started at 0.5 gm/kg/d of IVFE in the parenteral nutrition solution. Serum triglycerides were drawn daily. If serum triglyceride was 200 gm/dl or less the IVFE were increased by 0.5 gm/kg/d until a goal of 3 gm/kg/d were achieved in both groups. If hypertriglyceridemia occurred (201 gm/dl or greater) IVFE were decreased by study standard of care.

After infant had been on parenteral nutrition for 7 days checking daily triglycerides was stopped.

Eligibility

Ages Eligible for Study:	up to 2 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Appropriate for Gestation Age (AGA) infants who had a birthweight between 750-1500 grams admitted to the Neonatal Intensive Care Unit at Children's Hospital of Illinois

Exclusion Criteria:

Infants who were Small for Gestational Age (SGA) at birth, diagnosed with early sepsis, and who had congenital anormalities were excluded from this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516997

Locations

United States, Illinois
Children's Hospital of Illinois
Peoria, Illinois, United States, 61637

Sponsors and Collaborators

OSF Healthcare System

Investigators

Principal Investigator:

Kamlesh S Macwan, MD

University of Illinois College of Medicine at Peoria

More Information

No publications provided by OSF Healthcare System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00516997 History of Changes
Other Study ID Numbers:	821000-191100
Study First Received:	August 15, 2007
Last Updated:	August 15, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by OSF Healthcare System:

triglycerides
insulin
very low birthweight infants
necrotizing enterocolitis

retinopathy of prematurity
Hypertriglyceridemia (200 mg/dl or greater)
Hyperglycemia (200 mg/dl or greater)

Additional relevant MeSH terms:

Hyperglycemia
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases

Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on June 18, 2013