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

230 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug MOLE, SOLE for treating bronchopulmonary dysplasia?

Research suggests that lipid emulsions containing fish oil, which are rich in certain fatty acids, may help reduce inflammation and the development of bronchopulmonary dysplasia in very premature infants. ^{1 2 3 4 5}

Is the lipid emulsion treatment safe for humans?

Lipid emulsions, including those with olive oil and fish oil, are generally considered safe for preterm infants when used as part of their nutrition. They are well tolerated and can prevent essential fatty acid deficiency, though more research is needed to confirm long-term safety and benefits. ^{1 6 7 8 9}

How is the MOLE, SOLE treatment different from other treatments for bronchopulmonary dysplasia?

The MOLE, SOLE treatment is unique because it uses a lipid emulsion containing fish oil, which is rich in n-3 long-chain polyunsaturated fatty acids (LCPUFAs), to help reduce inflammation and improve immune function in very premature infants, potentially decreasing the risk of bronchopulmonary dysplasia. ^{1 2 3 4 10}

Research Team

Lindsay Holzapfel, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of SMOF lipid emulsion in very preterm infants does not affect the incidence of bronchopulmonary dysplasia-free survival. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Comparison of Alternative Lipid Emulsions on Morbidities in Very-Low-Birth-Weight Preterms. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Very low birth weight preterm infant complications where parenteral nutrition is soy or fish oil-based: A retrospective study in Shanghai. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Intravenous fish oil containing lipid emulsion attenuates inflammatory cytokines and the development of bronchopulmonary dysplasia in very premature infants: A double-blind, randomized controlled trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a lipid emulsion containing fish oil on polyunsaturated fatty acid profiles, growth and morbidities in extremely premature infants: A randomized controlled trial. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Pathological consequences to reticuloendothelial system organs following infusion of unstable all-in-one mixtures in rats. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Parenteral lipid emulsions in the preterm infant: current issues and controversies. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous lipids in preterm infants: impact on laboratory and clinical outcomes and long-term consequences. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition. [2015]