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Lipid Infusions to Optimize Nutrition Trial

NCT06915441 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-05-05

No results posted yet for this study

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

Conditions

  • Bronchopulmonary Dysplasia
  • Neurodevelopmental Impairment

Interventions

DRUG

SOLE

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

DRUG

MOLE

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Lindsay Holzapfel, MD, MS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-07-30
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915441 on ClinicalTrials.gov