NCT06915441

Lipid Infusions to Optimize Nutrition Trial

Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 12 Hours – 28 Weeks
• Healthy volunteers: Not accepted

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

Conditions

• Bronchopulmonary Dysplasia
• Neurodevelopmental Impairment

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-07-30
• Completion: 2030-12-31
• First posted: 2025-04-08
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study