Comparing two IV lipid infusions for very preterm or very low birth weight infants
Official title: Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial
Run by The University of Texas Health Science Center, Houston · NCT06915441 · Data updated 2026-11-12
This study will try two types of intravenous lipid emulsions (mixed-oil vs soybean-oil) in extremely preterm or very low birth weight infants to see which better prevents bronchopulmonary dysplasia and supports growth and brain development.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Hours to 28 Weeks |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | April 29, 2026 |
| Main results expected | July 30, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06915441 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants who are born at the enrolling hospital before 28 weeks gestation or with birth weight ≤1000 g and who survive at least 12 hours after birth and can be enrolled within 96 hours are ideal candidates.
✕Probably not a fit
Infants with major congenital anomalies, overt non-bacterial infection, those likely to be withdrawn from intensive care, or those who cannot be enrolled within the allowed time window are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Very preterm or very low birth weight infants who survive the first day of life will receive one of two intravenous lipid emulsions (mixed oil lipid emulsion, MOLE, versus soybean oil–based lipid emulsion, SOLE) as part of their nutrition. The trial will compare survival without bronchopulmonary dysplasia, blood fatty acid profiles, and early biochemical markers of oxidative stress between the two groups. Longer-term outcomes include discharge growth and neurodevelopment measured by the Bayley Scales of Infant Development IV at two years. The intervention is intended to determine whether changing the lipid composition of parenteral nutrition alters pulmonary outcomes, neonatal morbidities, and longer-term developmental outcomes.
Why it matters
Potential benefit: If successful, the MOLE approach could reduce lung disease and improve growth and neurodevelopment in extremely preterm or very low birth weight infants.
How similar studies have gone: Prior research has shown that mixed-oil emulsions can alter fatty acid profiles and reduce some inflammatory markers, but evidence that they reduce BPD or improve long-term neurodevelopment is limited and not conclusive.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Lindsay Holzapfel, MD, MS — The University of Texas Health Science Center, Houston
- Study coordinator: Lindsay F Holzapfel, MD, MS
- Email: Lindsay.N.Fleig@uth.tmc.edu
- Phone: (713) 500-6422
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This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.
-
Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.