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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University Texas Houston HSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intralipid	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.
Other: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (SMOF) lipid	Drug: Soybean oil Medium-chain triglycerides Olive oil Fish Oil (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Free Bilirubin (UB) Serum Levels	first day of infusion at 3 g/kg/day
Free Bilirubin (UB) Serum Levels	second day of infusion at 3 g/kg/day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	second day of infusion at 3 g/kg/day
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		first day of infusion at 3 g/kg/day
Mean Serum Triglyceride Level		second day of infusion at 3 g/kg/day

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Study Director: Cody Arnold, MD, UT Houston HSC

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2019
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: lipid emulsion; free fatty acids; parenteral nutrition; free bilirubin
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: HSC-MS-18-1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No