Skip to main content
OpenTrials
Completed

NCT Number: NCT03857646

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Hyperphagia Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

0 day–8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Texas Houston HSC

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intralipid, 20% Intravenous Emulsion

Drug

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) lipid

Drug

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.

Primary outcomes

  1. Free Bilirubin (UB) Serum Levels

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

  2. Free Bilirubin (UB) Serum Levels

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

Secondary outcomes

  1. Unbound Free Fatty Acid (FFAu) Serum Level

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

    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.

  2. Unbound Free Fatty Acid (FFAu) Serum Level

    Time frame: 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.

  3. Free Fatty Acid (Total) Serum Level

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

  4. Number of Participants With Direct Bilirubin >1.8 Milligrams Per Deciliter (mg/dL)

    Time frame: first and/or second days of infusion at 3 g/kg/day

  5. Number of Participants With Peak Serum Triglyceride Level >350 mg/dl

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

  6. Mean Serum Triglyceride Level

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

  7. Mean Serum Triglyceride Level

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2019
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.