NCT06915441 Lipid Infusions to Optimize Nutrition Trial
| NCT ID | NCT06915441 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 230 participants in total. It began in 2026-04-29 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Lindsay Holzapfel, MD, MS
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06915441 clinical trial?
This trial is open to participants of all sexes, aged 12 Hours or older, up to 28 Weeks, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06915441 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06915441 currently recruiting?
Yes, NCT06915441 is actively recruiting participants. Contact the research team at Lindsay.N.Fleig@uth.tmc.edu for enrollment information.
Where is the NCT06915441 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06915441 clinical trial?
NCT06915441 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Lindsay Holzapfel, MD, MS at The University of Texas Health Science Center, Houston. The trial plans to enroll 230 participants.