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

The University of Texas Health Science Center, Houston66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Prematurity

Interventions

Intralipid, 20% Intravenous EmulsionDRUG

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.

Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipidDRUG

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.

Eligibility

Sex: ALLMin age: 0 DaysMax age: 8 Days

Medical Language ↔ Plain English

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

Locations (1)

University Texas Houston HSC

Houston, Texas, United States

Outcomes

Primary Outcomes

Free Bilirubin (UB) Serum Levels

Time frame: first day of infusion at 3 g/kg/day

Free Bilirubin (UB) Serum Levels

Time frame: second day of infusion at 3 g/kg/day

Secondary Outcomes

Unbound Free Fatty Acid (FFAu) Serum Level

To measure unbound free fatty acid level, a fluorescent probe called Acrylodan-Labeled Intestinal Fatty Acid Binding Protein 2 (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.

Time frame: first day of infusion at 3 g/kg/day

Unbound Free Fatty Acid (FFAu) Serum Level

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.

Time frame: second day of infusion at 3 g/kg/day

Free Fatty Acid (Total) Serum Level

Data from ClinicalTrials.gov

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