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

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ClinicalTrials.gov Identifier: NCT03857646
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cody Arnold, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Prematurity Drug: Intralipid, 20% Intravenous Emulsion Drug: SMOF lipid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : April 15, 2020

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. free bilirubin serum levels [ Time Frame: first day of infusion at 3 g/kg/day ]
  2. free bilirubin serum levels [ Time Frame: second day of infusion at 3 g/kg/day ]

Secondary Outcome Measures :
  1. unbound free fatty acid serum level [ Time Frame: first day of infusion at 3 g/kg/day ]
  2. unbound free fatty acid serum level [ Time Frame: second day of infusion at 3 g/kg/day ]
  3. free fatty acid (total) serum level [ Time Frame: second day of infusion at 3 g/kg/day of infusion at 3 g/kg/day ]
  4. number of participants with peak serum triglyceride level >350 mg/dl [ Time Frame: first and second days of infusion at 3 g/kg/day ]
  5. mean serum triglyceride level [ Time Frame: first and second days of infusion at 3 g/kg/day ]


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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857646


Contacts
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Contact: Meredith Collins, MD 678-575-9580 meredith.d.collins@uth.tmc.edu

Locations
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United States, Texas
University Texas Houston HSC
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Study Director: Cody Arnold, MD UT Houston HSC

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Responsible Party: Cody Arnold, Cody Arnold MD Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03857646     History of Changes
Other Study ID Numbers: HSC-MS-18-1000
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Cody Arnold, The University of Texas Health Science Center, Houston:
parenteral nutrition
lipid emulsion
free bilirubin
free fatty acids

Additional relevant MeSH terms:
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Bilirubin
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs