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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
Who can join
12 Hours – 28 Weeks · All sexes
Full eligibility criteria
Inclusion Criteria: * inborn \<28 weeks gestational age (GA) or ≤1000g birth weight (BW) * survives until 12 hours after birth. Exclusion Criteria: * 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.
About the study
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
What is being tested
- SOLE (drug)
- MOLE (drug)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 230 · Started: Apr 29, 2026
Contact the study team
- Lindsay F Holzapfel, MD, MS · Phone: (713) 500-6422
- Emily Stephens · Phone: (713) 500-5734
Official record on ClinicalTrials.gov — NCT06915441
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.