RecruitingPhase 2NCT06915441

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

230 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 HoursMax Age: 28 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MOLE and a drug called SOLE for people with bronchopulmonary dysplasia and neurodevelopmental impairment. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Hours to 28 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSOLE

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

DRUGMOLE

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

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NCT06915441


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