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

May 27, 2021 updated by: Cody Arnold, The University of Texas Health Science Center, Houston
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: SMOF lipid
Drug: 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 serum levels
Time Frame: first day of infusion at 3 g/kg/day
first day of infusion at 3 g/kg/day
free bilirubin serum levels
Time Frame: second day of infusion at 3 g/kg/day
second day of infusion at 3 g/kg/day

Secondary Outcome Measures

Outcome Measure
Time Frame
unbound free fatty acid serum level
Time Frame: first day of infusion at 3 g/kg/day
first day of infusion at 3 g/kg/day
unbound free fatty acid serum level
Time Frame: second day of infusion at 3 g/kg/day
second day of infusion at 3 g/kg/day
free fatty acid (total) serum level
Time Frame: second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day
second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day
number of participants with peak serum triglyceride level >350 mg/dl
Time Frame: first and second days of infusion at 3 g/kg/day
first and second days of infusion at 3 g/kg/day
mean serum triglyceride level
Time Frame: first and second days of infusion at 3 g/kg/day
first and second days of infusion at 3 g/kg/day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Study Director: Cody Arnold, MD, UT Houston HSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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