NCT06915441PHASE2Recruiting

Lipid Infusions to Optimize Nutrition Trial

The University of Texas Health Science Center, Houston

Start Date

5/1/2026

Completion Date

12/31/2030

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 Criteria

Age Range: No minimum to No maximum

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.

Interventions

DRUG

SOLE

DRUG

MOLE

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Conditions

Bronchopulmonary DysplasiaNeurodevelopmental Impairment

Locations

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States