Clinical Research Directory
Browse clinical research sites, groups, and studies.
Lipid Infusions to Optimize Nutrition Trial
Sponsor: The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based lipid emulsion (SOLE) and to establish whether MOLE or SOLE is more effective in minimizing pulmonary outcomes, neonatal morbidities, long-term morbidity and mortality, and improving discharge growth and Bayley Scales of Infant Development Fourth Edition (BSID-IV) neurodevelopmental assessment at two years
Official title: Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
12 Hours - 28 Weeks
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2026-03-01
Completion Date
2030-12-31
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
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
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States