Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 6 months
Healthy Volunteers: f
View:
• inborn \<28 weeks gestational age (GA) or ≤1000g birth weight (BW)
• survives until 12 hours after birth.
Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Lindsay F Holzapfel, MD, MS
Lindsay.N.Fleig@uth.tmc.edu
(713) 500-6422
Backup
Emily Stephens
Emily.K.Stephens@uth.tmc.edu
(713) 500-5734
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 230
Treatments
Experimental: SOLE
Active_comparator: MOLE
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston