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NCT Number: NCT06915441

Lipid Infusions to Optimize Nutrition 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

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Neurodevelopmental Impairment Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

12 hour–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOLE

Drug

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

MOLE

Drug

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

Primary outcomes

  1. Number of participants free of BPD (infants breathing in room air)

    Time frame: 36 weeks post menstrual age (PMA)

Secondary outcomes

  1. 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)

  2. Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    Time frame: baseline before LE exposure

  3. Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    Time frame: end of the intervention period (28±3 postnatal days)

  4. Relative mole percentages of Docosahexaenoic acid (DHA) in plasma

    Time frame: 36 weeks postmenstrual age (±3 days)

  5. 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)

  6. Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma

    Time frame: baseline before LE exposure

  7. Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma

    Time frame: end of the intervention period (28±3 postnatal days)

  8. Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma

    Time frame: 36 weeks postmenstrual age (±3 days)

  9. 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)

  10. Relative mole percentages of Arachidonic acid (ARA) in plasma

    Time frame: baseline before LE exposure

  11. Relative mole percentages of Arachidonic acid (ARA) in plasma

    Time frame: end of the intervention period (28±3 postnatal days)

  12. Relative mole percentages of Arachidonic acid (ARA) in plasma

    Time frame: 36 weeks postmenstrual age (±3 days)

  13. 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)

  14. Relative mole percentages of linoleic acid (LA) in plasma

    Time frame: baseline before LE exposure

  15. Change in relative mole percentages of linoleic acid (LA) in plasma

    Time frame: end of the intervention period (28±3 postnatal days)

  16. Change in relative mole percentages of linoleic acid (LA) in plasma

    Time frame: 36 weeks postmenstrual age (±3 days)

  17. 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)

  18. 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)

  19. 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)

  20. Amount of superoxide dismutase

    Time frame: baseline before LE exposure

  21. Amount of superoxide dismutase

    Time frame: end of the intervention period (28±3 postnatal days)

  22. Amount of superoxide dismutase

    Time frame: 36 weeks postmenstrual age (±3 days)

  23. Glutathione ratio

    Time frame: baseline before LE exposure

  24. Glutathione ratio

    Time frame: end of the intervention period (28±3 postnatal days)

  25. Glutathione ratio

    Time frame: 36 weeks postmenstrual age (±3 days)

  26. Amount of lipid peroxidase

    Time frame: baseline before LE exposure

  27. Amount of lipid peroxidase

    Time frame: end of the intervention period (28±3 postnatal days)

  28. Amount of lipid peroxidase

    Time frame: 36 weeks postmenstrual age (±3 days)

  29. 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

  30. Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)

    Time frame: before discharge (~ 36 weeks post menstrual age), two years

  31. Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)

    Time frame: before discharge (~ 36 weeks post menstrual age), two years

  32. 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

  33. 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

  34. 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

  35. 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)

  36. 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)

  37. 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)

  38. 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.

  39. Mechanical ventilation days

    Time frame: Discharge (about 3 months from birth)

  40. Number of days participants are exposed to oxygen

    Time frame: Discharge (about 3 months from birth)

  41. Number of chronic lung disease re-hospitalizations

    Time frame: after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age

  42. Number of participants that develop late onset sepsis

    Time frame: Discharge (about 3 months from birth)

  43. Number of participants that develop cholestasis

    Time frame: Discharge (about 3 months from birth)

  44. Weight of participant

    Time frame: Discharge (about 3 months from birth)

  45. Length of participant

    Time frame: Discharge (about 3 months from birth)

  46. Head circumference of participant

    Time frame: Discharge (about 3 months from birth)

  47. Number of participants that die

    Time frame: Discharge (about 3 months from birth)

  48. Number of participants that die

    Time frame: at 2 years

  49. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Stephens

CONTACT

[email protected]

(713) 500-5734

Lindsay F Holzapfel, MD, MS

CONTACT

[email protected]

(713) 500-6422

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Comparative Effectiveness Trial

Acronym: LION

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Apr 8, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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