RecruitingPhase 2

Lipid Infusions to Optimize Nutrition Trial

United States230 participantsStarted 2026-05-01

Plain-language 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

Who can participate

Age range12 Hours – 28 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of participants free of BPD (infants breathing in room air)

Timeframe: 36 weeks post menstrual age (PMA)

Trial details

NCT IDNCT06915441

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-30

Contact for this trial

Lindsay F Holzapfel, MD, MS

(713) 500-6422 Lindsay.N.Fleig@uth.tmc.edu

View on ClinicalTrials.gov More Bronchopulmonary Dysplasia trials