Lipid Infusions to Optimize Nutrition Trial (LION)

August 3, 2026 updated by: Lindsay Fleig Holzapfel, MD, The University of Texas Health Science Center, Houston

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOLE
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
Active Comparator: MOLE
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants free of BPD (infants breathing in room air)
Time Frame: 36 weeks post menstrual age (PMA)
36 weeks post menstrual age (PMA)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
baseline before LE exposure
Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
Time Frame: end of the intervention period (28±3 postnatal days)
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)
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)
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
baseline before LE exposure
Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
Time Frame: end of the intervention period (28±3 postnatal days)
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)
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)
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
baseline before LE exposure
Relative mole percentages of Arachidonic acid (ARA) in plasma
Time Frame: end of the intervention period (28±3 postnatal days)
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)
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)
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
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)
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)
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)
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)
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)
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
baseline before LE exposure
Amount of superoxide dismutase
Time Frame: end of the intervention period (28±3 postnatal days)
end of the intervention period (28±3 postnatal days)
Amount of superoxide dismutase
Time Frame: 36 weeks postmenstrual age (±3 days)
36 weeks postmenstrual age (±3 days)
Glutathione ratio
Time Frame: baseline before LE exposure
baseline before LE exposure
Glutathione ratio
Time Frame: end of the intervention period (28±3 postnatal days)
end of the intervention period (28±3 postnatal days)
Glutathione ratio
Time Frame: 36 weeks postmenstrual age (±3 days)
36 weeks postmenstrual age (±3 days)
Amount of lipid peroxidase
Time Frame: baseline before LE exposure
baseline before LE exposure
Amount of lipid peroxidase
Time Frame: end of the intervention period (28±3 postnatal days)
end of the intervention period (28±3 postnatal days)
Amount of lipid peroxidase
Time Frame: 36 weeks postmenstrual age (±3 days)
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
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
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
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
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
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
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)
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)
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)
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
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.
2 years corrected age
Mechanical ventilation days
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Number of days participants are exposed to oxygen
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Number of chronic lung disease re-hospitalizations
Time Frame: after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age
after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age
Number of participants that develop late onset sepsis
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Number of participants that develop cholestasis
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Weight of participant
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Length of participant
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Head circumference of participant
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Number of participants that die
Time Frame: Discharge (about 3 months from birth)
Discharge (about 3 months from birth)
Number of participants that die
Time Frame: at 2 years
at 2 years
Number of participants that develop Neonatal Morbidity
Time Frame: Discharge (about 3 months from birth)
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.
Discharge (about 3 months from birth)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsay Holzapfel, MD, MS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-24-1129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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