Lipid Emulsions for Bronchopulmonary Dysplasia

(LION Trial)

Overseen By Emily Stephens

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Major anomaly, Non-bacterial infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of fat-based treatments, MOLE and SOLE, to determine which better helps babies with very early births avoid lung problems called bronchopulmonary dysplasia (BPD). Researchers aim to discover if these treatments can also enhance growth and brain development by age two. Babies born before 28 weeks or weighing less than 1000 grams who survive the first 12 hours of life may be eligible to join. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important early findings.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that soybean oil-based lipid emulsions (SOLE) are generally safe for newborns. In earlier studies, a few patients developed conditions like bronchopulmonary dysplasia (BPD), but these cases were rare. Most patients tolerated the treatment well, with only a few serious side effects reported.

For mixed oil lipid emulsion (MOLE), specific data from available sources is lacking. However, the trial's phase 2 status indicates that earlier tests demonstrated MOLE to be safe enough for further study, even though not all risks are fully known. Both treatments are expected to be quite safe, but participants will be closely monitored for any side effects during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, MOLE and SOLE, for bronchopulmonary dysplasia (BPD) because they offer innovative approaches compared to traditional options like oxygen therapy and mechanical ventilation. MOLE is unique as it acts as an active comparator, potentially providing a new benchmark in treatment effectiveness. SOLE, as an experimental treatment, introduces a novel lipid emulsion approach, which might enhance lung health more effectively by targeting the inflammation and damage in a different manner than current methods. These treatments could offer new hope for infants with BPD, aiming for better outcomes and fewer side effects.

What evidence suggests that this trial's treatments could be effective for bronchopulmonary dysplasia?

This trial will compare two treatments for bronchopulmonary dysplasia (BPD) in very low birth weight infants: soybean oil-based lipid emulsions (SOLE) and mixed oil lipid emulsions (MOLE). Research has shown that SOLE has been studied for its effects on BPD, but the rates of BPD in infants using SOLE remain high, between 32% and 45%. This suggests that while SOLE helps manage BPD, it may not significantly lower BPD rates. In contrast, MOLE, another treatment option in this trial, is being explored for its potential to reduce lung problems and improve health outcomes in infants with BPD. MOLE is thought to work by providing a better mix of fatty acids, which might aid growth and development more than SOLE. Early research suggests MOLE could be more effective, but more evidence is needed to confirm these benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Lindsay Holzapfel, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for infants with developmental delays or bronchopulmonary dysplasia (BPD). It's not specified who can't join, but typically those with conditions that could interfere with the study or pose a risk to their health would be excluded.

Inclusion Criteria

My baby lived for at least 12 hours after birth.

My baby was born before 28 weeks or weighed 1000g or less.

Exclusion Criteria

My infant is older than 96 hours since birth.

My infant has significant birth defects.

Infants likely to expire soon, defined as limiting or withdrawal of intensive care recommended or requested by the parents.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mixed oil lipid emulsion (MOLE) or soybean oil-based lipid emulsion (SOLE) to assess survival free of bronchopulmonary dysplasia and other outcomes

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurodevelopmental assessment at two years

2 years

What Are the Treatments Tested in This Trial?

Interventions

• MOLE
• SOLE

Trial Overview The study compares two types of lipid infusions: MOLE (mixed oil lipid emulsion) and SOLE (soybean oil-based lipid emulsion), to see which one better supports growth, development, and survival without BPD in affected infants.

How Is the Trial Designed?

Group I: SOLE Experimental Treatment 1 Intervention

Group II: MOLE Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study involving 78 critically ill neonates, an olive oil-based lipid emulsion (ClinOleic) was found to be well tolerated with no adverse events, indicating its safety for use in this vulnerable population.

After 5 days of treatment, the olive oil emulsion significantly increased plasma levels of oleic acid compared to a soybean oil emulsion, while also showing a lower increase in linoleic acid, reflecting the different fatty acid compositions of the emulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial. Webb, AN., Hardy, P., Peterkin, M., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10715505/

Respiratory management and outcomes in high-risk ... Over the study period, mortality decreased (10.1%–8.5%), with increases in BPD (28%–33%), severe BPD (12%–17%), composite BPD/death (35%–39%) ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2781459

Rates of Bronchopulmonary Dysplasia Following ... This quality improvement study assesses whether a consistent, systematic prevention system of care decreases the rate of bronchopulmonary ...

3. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02850-x

Rates of bronchopulmonary dysplasia in very low birth weight ... However, the rates of bronchopulmonary dysplasia (BPD36) in their study ranged from 32 to 45%, which is notably higher than the 21% observed in ...

4. bmjpaedsopen.bmj.com bmjpaedsopen.bmj.com/content/9/1/e003652

Machine learning-based risk prediction models for ... This study provides the first comprehensive analysis of BPD risk factors at a specific high altitude and validates effective, interpretable machine learning ...

5. nature.com nature.com/articles/s41598-025-98087-9

Development and external validation of a machine learning ... The primary outcome was moderate or severe bronchopulmonary dysplasia. We assessed both static perinatal risk factors and dynamic factors, such ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8319211/

Parenteral lipid emulsions in the preterm infant: current issues ... A recently published meta-analysis found no benefit of fish oil-containing lipid emulsions for prevention of bronchopulmonary dysplasia (BPD).

7. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.11327

Narrative review of micronutrients and fatty acids in ... It has been shown that fish oil–containing lipid emulsions can reduce the inflammatory response and oxidative stress in neonates. Furthermore, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06915441

Study Details | NCT06915441 | Lipid Infusions to Optimize ... The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624010721

Safety and Efficacy of a Composite Lipid Emulsion with ... Bronchopulmonary dysplasia was seen in 2 and 1 patients, retinopathy of prematurity in 0 and 1 patients, intraventricular hemorrhage in 1 and 0 patients ...

10. withpower.com withpower.com/trial/phase-2-neurodevelopmental-impairment-6-2025-aef2c

Lipid Emulsions for Bronchopulmonary Dysplasia In a study involving 78 critically ill neonates, an olive oil-based lipid emulsion (ClinOleic) was found to be well tolerated with no adverse events, indicating ...