Lipid Infusions to Optimize Nutrition Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06915441
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia
  • Neurodevelopmental Impairment

Eligibility Criteria

Sex
ALL
Age
12 Hours - 28 Weeks
Healthy Volunteers
Not accepted

Interventions

  • SOLE — DRUG
    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
  • MOLE — DRUG
    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

Study Details

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

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Jul 30, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: SOLE
  • Active Comparator: MOLE

Primary Outcome Measure

Number of participants free of BPD (infants breathing in room air) [ Time Frame: 36 weeks post menstrual age (PMA) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Lindsay Holzapfel, MD, MS
[email protected]
713-500-6422
Emily Stephens
[email protected]
(713) 500-5734

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