Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2026-03-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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SOLE
SOLE
Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level \<250 mg/dL, per clinical team
MOLE
MOLE
Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level \<250 mg/dL, per clinical team
Interventions
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SOLE
Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level \<250 mg/dL, per clinical team
MOLE
Participants will first receive LE at 1 g/kg/day, then will advance to 2 g/kg/day and lastly to 3 g/kg/day as tolerated to titrate based on triglyceride level \<250 mg/dL, per clinical team
Eligibility Criteria
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Inclusion Criteria
* survives until 12 hours after birth.
Exclusion Criteria
* Major anomaly
* Overt non-bacterial infection
* Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.
12 Hours
28 Weeks
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Lindsay Fleig Holzapfel, MD
Assistant Professor
Principal Investigators
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Lindsay Holzapfel, MD, MS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-24-1129
Identifier Type: -
Identifier Source: org_study_id
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