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

Phase 4

Completed

• Conditions: Prematurity
• Interventions: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid

• Registration Number: NCT03857646
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Study Start: 2019-03-02
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11
• Disposition First Submitted: 2021-05-27
• Results First Submitted: 2022-06-30
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Results First Posted: 2025-03-03
• Disposition First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralipid	Intralipid, 20% Intravenous Emulsion	-
Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	-

Primary Outcome Measures

Name	Time	Method
Free Bilirubin (UB) Serum Levels	second day of infusion at 3 g/kg/day

Secondary Outcome Measures

Name	Time	Method
Unbound Free Fatty Acid (FFAu) Serum Level	second day of infusion at 3 g/kg/day	To measure unbound free fatty acid level, a fluorescent probe called ADIFAB2 was used. The ADIFAB2 fluorescent probe is a fatty acid binding protein complexed with a fluorescent group. Once mixed with a sample, the ADIFAB2 fluorescent probe binds all unbound free fatty acid in the sample; therefore, measurement of fluorescence indicates the amount of unbound free fatty acid in the sample. After binding of the ADIFAB2 fluorescent probe to the sample, fluorescence intensities are measured at two wavelengths (550 nanometers and 457 nanometers), and for this outcome measure the R value is reported. The R value is the ratio of the fluorescence intensity at 550 nanometers to the fluorescence intensity at 457 nanometers.
Free Fatty Acid (Total) Serum Level	second day of infusion at 3 g/kg/day
Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)	first and/or second days of infusion at 3 g/kg/day
Number of Participants With Peak Serum Triglyceride Level >350 mg/dl	first or second days of infusion at 3 g/kg/day
Mean Serum Triglyceride Level	second day of infusion at 3 g/kg/day

Trial Locations

Locations (1)

University Texas Houston HSC; 🇺🇸 Houston, Texas, United States