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
The University of Texas Health Science Center, Houston
230 participants
May 1, 2026
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
Inclusion Criteria2
- inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)
- survives until 12 hours after birth.
Exclusion Criteria4
- Infants who are unable to be enrolled by 96 hours postnatal age
- 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.
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Interventions
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
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)
View Full Details on ClinicalTrials.gov
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NCT06915441