Increase Infusion Rates of Intravenous Fat Emulsions

Hyperglycemia Clinical Trial

Official title:

Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516997
• Other study ID #: 821000-191100
• Status: Completed
• Phase: N/A
• First received: August 15, 2007
• Last updated: May 13, 2016
• Start date: June 2005
• Est. completion date: February 2007

Study information

• Verified date: August 2007
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Hypertriglyceridemia

Intervention

Other:
• fat emulsions
Intravenous Fat Emulsions were increased by 0.5 grams/kg/day daily until goal 3 gm/kg/d
• fat emulsions
IVFE were increased daily by 05 gm/kg/d until goal of 3 gm/kg/d

Locations

Country	Name	City	State
United States	Children's Hospital of Illinois	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		For 7 days after starting parenteral nutrition
Secondary	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.		7 days after starting parenteral nutrition
Secondary	To achieve a return to birth weight for VLBW infants significantly sooner.		Two weeks after birth
Secondary	To maintain blood sugar levels of VLBW infants at less than 200mg/dl.		7 days after starting parenteral nutrition