Status:

COMPLETED

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

Lead Sponsor:

The University of Texas Health Science Center, Houston

Conditions:

Prematurity

Eligibility:

All Genders

Up to 8 years

Phase:

PHASE4

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 2 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 11 2020

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT03857646

Start Date

March 2 2019

End Date

June 11 2020

Last Update

March 3 2025

Active Locations (1)

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1

University Texas Houston HSC

Houston, Texas, United States, 77030