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

Primary Purpose

Prematurity

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Intralipid, 20% Intravenous Emulsion

SMOF lipid

About this trial

This is an interventional treatment trial for Prematurity focused on measuring parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids

Eligibility Criteria

0 Days - 8 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Texas Houston HSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intralipid

SMOF lipid

Arm Description

Outcomes

Primary Outcome Measures

free bilirubin serum levels

Secondary Outcome Measures

unbound free fatty acid serum level

free fatty acid (total) serum level

number of participants with peak serum triglyceride level >350 mg/dl

mean serum triglyceride level

Full Information

NCT ID

NCT03857646

First Posted

February 26, 2019

Last Updated

May 27, 2021

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03857646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 2, 2019 (Actual)

Primary Completion Date

June 11, 2020 (Actual)

Study Completion Date

June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity

Keywords

parenteral nutrition, lipid emulsion, free bilirubin, free fatty acids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intralipid

Arm Type

Other

Arm Title

SMOF lipid

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Intralipid, 20% Intravenous Emulsion

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

SMOF lipid

Intervention Description

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 Outcome Measure Information:

Title

free bilirubin serum levels

Time Frame

first day of infusion at 3 g/kg/day

Title

free bilirubin serum levels

Time Frame

second day of infusion at 3 g/kg/day

Secondary Outcome Measure Information:

Title

unbound free fatty acid serum level

Time Frame

first day of infusion at 3 g/kg/day

Title

unbound free fatty acid serum level

Time Frame

second day of infusion at 3 g/kg/day

Title

free fatty acid (total) serum level

Time Frame

second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day

Title

number of participants with peak serum triglyceride level >350 mg/dl

Time Frame

first and second days of infusion at 3 g/kg/day

Title

mean serum triglyceride level

Time Frame

first and second days of infusion at 3 g/kg/day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Days

Maximum Age & Unit of Time

8 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cody Arnold, MD

Organizational Affiliation

UT Houston HSC

Official's Role

Study Director

Facility Information:

Facility Name

University Texas Houston HSC

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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