The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Prematurity Clinical Trial

Official title:

The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857646
• Other study ID #: HSC-MS-18-1000
• Status: Completed
• Phase: Phase 4
• Start date: March 2, 2019
• Est. completion date: June 11, 2020

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to compare the levels of free fatty acids and free bilirubin between two intravenous lipid emulsion products in premature newborns.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Days

Eligibility

Inclusion Criteria:

• premature newborns (<32 weeks gestation, stratified <28 weeks versus >28 weeks) <8 days of age

• receiving lipid infusions <1 g/kg/day at enrollment

• anticipated to be treated with 3 g/kg/day for a minimum of 48 hours.

Exclusion Criteria:

• patients with direct hyperbilirubinemia >1.5 mg/dl

• with suspected sepsis meeting Systemic inflammatory response syndrome (SIRS) criteria

• undergoing treatment with a continuous infusion of morphine

• with a continuous infusion of pressors (dopamine, dobutamine, epinephrine, etc.)

• positive blood cultures

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Drug:
• Intralipid, 20% Intravenous Emulsion
Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
• SMOF lipid
Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.

Locations

Country	Name	City	State
United States	University Texas Houston HSC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free bilirubin serum levels		first day of infusion at 3 g/kg/day
Primary	free bilirubin serum levels		second day of infusion at 3 g/kg/day
Secondary	unbound free fatty acid serum level		first day of infusion at 3 g/kg/day
Secondary	unbound free fatty acid serum level		second day of infusion at 3 g/kg/day
Secondary	free fatty acid (total) serum level		second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day
Secondary	number of participants with peak serum triglyceride level >350 mg/dl		first and second days of infusion at 3 g/kg/day
Secondary	mean serum triglyceride level		first and second days of infusion at 3 g/kg/day