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NCT03857646 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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