Bronchopulmonary DysplasiaPhase 2LIONNCT06915441
Lipid Infusions to Optimize Nutrition Trial
A Phase 2 study testing SOLE and MOLE in people with Bronchopulmonary Dysplasia and Neurodevelopmental Impairment, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 hours to 28 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Neurodevelopmental Impairment
- What is being tested?
- SOLE and MOLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 hours to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)
- survives until 12 hours after birth.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lindsay Holzapfel, MD, MS, 713-500-6422, Lindsay.N.Fleig@uth.tmc.edu
Emily Stephens, (713) 500-5734, Emily.K.Stephens@uth.tmc.edu
About this study
Official title: Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness 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
- Being tested
- SOLE, MOLE
- Keywords
- soybean oil-based lipid emulsion (SOLE), mixed oil lipid emulsion (MOLE)
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLEDrug
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
MOLEDrug
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 group | Role | What they receive |
|---|---|---|
| SOLE | Experimental | Not described Receives: Drug: SOLE |
| MOLE | Active comparator | Not described Receives: Drug: MOLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free of BPD (infants breathing in room air)
Measured: 36 weeks post menstrual age (PMA)
Secondary outcomes (49)
Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Measured: baseline before LE exposure
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Measured: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Measured: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Measured: baseline before LE exposure
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Measured: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Measured: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of Arachidonic acid (ARA) in plasma
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Arachidonic acid (ARA) in plasma
Measured: baseline before LE exposure
Relative mole percentages of Arachidonic acid (ARA) in plasma
Measured: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Arachidonic acid (ARA) in plasma
Measured: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of linoleic acid (LA) in plasma
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of linoleic acid (LA) in plasma
Measured: baseline before LE exposure
Change in relative mole percentages of linoleic acid (LA) in plasma
Measured: end of the intervention period (28±3 postnatal days)
Change in relative mole percentages of linoleic acid (LA) in plasma
Measured: 36 weeks postmenstrual age (±3 days)
Change in Urine oxidative stress marker, superoxide dismutase
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Change in Urine oxidative stress marker, lipid peroxidase
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Change in glutathione ratio
Measured: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Amount of superoxide dismutase
Measured: baseline before LE exposure
Amount of superoxide dismutase
Measured: end of the intervention period (28±3 postnatal days)
Amount of superoxide dismutase
Measured: 36 weeks postmenstrual age (±3 days)
Glutathione ratio
Measured: baseline before LE exposure
Glutathione ratio
Measured: end of the intervention period (28±3 postnatal days)
Glutathione ratio
Measured: 36 weeks postmenstrual age (±3 days)
Amount of lipid peroxidase
Measured: baseline before LE exposure
Amount of lipid peroxidase
Measured: end of the intervention period (28±3 postnatal days)
Amount of lipid peroxidase
Measured: 36 weeks postmenstrual age (±3 days)
Change in lung reactance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in resonance frequency as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in tidal volume as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in respiratory rate as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Measured: before discharge (~ 36 weeks post menstrual age), two years
Change in weight of participant
Measured: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Change in length of participant
Measured: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Change in head circumference of participant
Measured: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Neurodevelopmental development as assessed by the Bayley Scales of Infants Development Version IV (BSID-IV)
The following domains will be assessed: composite motor, language and cognition.Range of composite score is from 40-160.Composite scores (mean = 100; Standard Deviation = 15) will be reported, with higher scores reflecting better developmental outcomes.
Measured: 2 years corrected age
Mechanical ventilation days
Measured: Discharge (about 3 months from birth)
Number of days participants are exposed to oxygen
Measured: Discharge (about 3 months from birth)
Number of chronic lung disease re-hospitalizations
Measured: after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age
Number of participants that develop late onset sepsis
Measured: Discharge (about 3 months from birth)
Number of participants that develop cholestasis
Measured: Discharge (about 3 months from birth)
Weight of participant
Measured: Discharge (about 3 months from birth)
Length of participant
Measured: Discharge (about 3 months from birth)
Head circumference of participant
Measured: Discharge (about 3 months from birth)
Number of participants that die
Measured: Discharge (about 3 months from birth)
Number of participants that die
Measured: at 2 years
Number of participants that develop Neonatal Morbidity
Neonatal Morbidity may include severe intraventricular hemorrhage, surgical necrotizing enterocolitis (stage 2A or greater), severe retinopathy of prematurity (Stage 2 or greater or with plus disease), hearing loss, severe bronchopulmonary dysplasia or death.
Measured: Discharge (about 3 months from birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start29 Apr 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Fleig Holzapfel, MD, The University of Texas Health Science Center, Houston
- Investigators
- Lindsay Holzapfel, MD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915441
- Sponsor's protocol ID
- HSC-MS-24-1129
- Acronym
- LION
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT06915441
- Acronym / sponsor ID
- LION / HSC-MS-24-1129
- Keywords
- soybean oil-based lipid emulsion (SOLE), mixed oil lipid emulsion (MOLE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOLE | Experimental | Drug: SOLE |
| MOLE | Active comparator | Drug: MOLE |
Who may qualify
- Ages
- 12 hours to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- inborn <28 weeks gestational age (GA) or ≤1000g birth weight (BW)
- survives until 12 hours after birth.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLEParticipants 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 | SOLE |
| MOLEParticipants 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 |
Primary outcome
Number of participants free of BPD (infants breathing in room air)
Time frame: 36 weeks post menstrual age (PMA)
49 secondary outcomes
Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Time frame: baseline before LE exposure
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Time frame: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Time frame: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Time frame: baseline before LE exposure
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Time frame: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Time frame: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of Arachidonic acid (ARA) in plasma
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of Arachidonic acid (ARA) in plasma
Time frame: baseline before LE exposure
Relative mole percentages of Arachidonic acid (ARA) in plasma
Time frame: end of the intervention period (28±3 postnatal days)
Relative mole percentages of Arachidonic acid (ARA) in plasma
Time frame: 36 weeks postmenstrual age (±3 days)
Change in relative mole percentages of linoleic acid (LA) in plasma
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Relative mole percentages of linoleic acid (LA) in plasma
Time frame: baseline before LE exposure
Change in relative mole percentages of linoleic acid (LA) in plasma
Time frame: end of the intervention period (28±3 postnatal days)
Change in relative mole percentages of linoleic acid (LA) in plasma
Time frame: 36 weeks postmenstrual age (±3 days)
Change in Urine oxidative stress marker, superoxide dismutase
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Change in Urine oxidative stress marker, lipid peroxidase
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Change in glutathione ratio
Time frame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
Amount of superoxide dismutase
Time frame: baseline before LE exposure
Amount of superoxide dismutase
Time frame: end of the intervention period (28±3 postnatal days)
Amount of superoxide dismutase
Time frame: 36 weeks postmenstrual age (±3 days)
Glutathione ratio
Time frame: baseline before LE exposure
Glutathione ratio
Time frame: end of the intervention period (28±3 postnatal days)
Glutathione ratio
Time frame: 36 weeks postmenstrual age (±3 days)
Amount of lipid peroxidase
Time frame: baseline before LE exposure
Amount of lipid peroxidase
Time frame: end of the intervention period (28±3 postnatal days)
Amount of lipid peroxidase
Time frame: 36 weeks postmenstrual age (±3 days)
Change in lung reactance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in resonance frequency as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in tidal volume as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in respiratory rate as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
Time frame: before discharge (~ 36 weeks post menstrual age), two years
Change in weight of participant
Time frame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Change in length of participant
Time frame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Change in head circumference of participant
Time frame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
Neurodevelopmental development as assessed by the Bayley Scales of Infants Development Version IV (BSID-IV)
Time frame: 2 years corrected age
Mechanical ventilation days
Time frame: Discharge (about 3 months from birth)
Number of days participants are exposed to oxygen
Time frame: Discharge (about 3 months from birth)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Holzapfel, MD, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOLE and MOLE in people with Bronchopulmonary Dysplasia and Neurodevelopmental Impairment, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay F Holzapfel, MD, MS ((713) 500-6422, Lindsay.N.Fleig@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free of BPD (infants breathing in room air) (time frame: 36 weeks post menstrual age (PMA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.