Clinical trial NCT06915441: Lipid Infusions to Optimize Nutrition Trial
Official title: Lipid Infusions to Optimize Nutrition (LION) and Minimize Bronchopulmonary Dysplasia and Neurodevelopmental Impairment in Extremely Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Neurodevelopmental Impairment
Keywords: soybean oil-based lipid emulsion (SOLE)
mixed oil lipid emulsion (MOLE)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 230
Sex: ALL
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants free of BPD (infants breathing in room air)
timeFrame: 36 weeks post menstrual age (PMA)
Secondary outcomes:
measure: Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
timeFrame: baseline before LE exposure
measure: Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Relative mole percentages of Docosahexaenoic acid (DHA) in plasma
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
timeFrame: baseline before LE exposure
measure: Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Change in relative mole percentages of Arachidonic acid (ARA) in plasma
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Relative mole percentages of Arachidonic acid (ARA) in plasma
timeFrame: baseline before LE exposure
measure: Relative mole percentages of Arachidonic acid (ARA) in plasma
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Relative mole percentages of Arachidonic acid (ARA) in plasma
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Change in relative mole percentages of linoleic acid (LA) in plasma
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Relative mole percentages of linoleic acid (LA) in plasma
timeFrame: baseline before LE exposure
measure: Change in relative mole percentages of linoleic acid (LA) in plasma
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Change in relative mole percentages of linoleic acid (LA) in plasma
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Change in Urine oxidative stress marker, superoxide dismutase
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Change in Urine oxidative stress marker, lipid peroxidase
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Change in glutathione ratio
timeFrame: baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days)
measure: Amount of superoxide dismutase
timeFrame: baseline before LE exposure
measure: Amount of superoxide dismutase
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Amount of superoxide dismutase
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Glutathione ratio
timeFrame: baseline before LE exposure
measure: Glutathione ratio
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Glutathione ratio
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Amount of lipid peroxidase
timeFrame: baseline before LE exposure
measure: Amount of lipid peroxidase
timeFrame: end of the intervention period (28±3 postnatal days)
measure: Amount of lipid peroxidase
timeFrame: 36 weeks postmenstrual age (±3 days)
measure: Change in lung reactance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in resonance frequency as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in tidal volume as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in respiratory rate as assessed by the Non-Invasive Functional Oscillometry Test (FOT)
timeFrame: before discharge (~ 36 weeks post menstrual age), two years
measure: Change in weight of participant
timeFrame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
measure: Change in length of participant
timeFrame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
measure: Change in head circumference of participant
timeFrame: baseline, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age, at discharge (~ 40 weeks post menstrual age)
measure: Neurodevelopmental development as assessed by the Bayley Scales of Infants Development Version IV (BSID-IV)
timeFrame: 2 years corrected age
measure: Mechanical ventilation days
timeFrame: Discharge (about 3 months from birth)
measure: Number of days participants are exposed to oxygen
timeFrame: Discharge (about 3 months from birth)
measure: Number of chronic lung disease re-hospitalizations
timeFrame: after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age
measure: Number of participants that develop late onset sepsis
timeFrame: Discharge (about 3 months from birth)
measure: Number of participants that develop cholestasis
timeFrame: Discharge (about 3 months from birth)
measure: Weight of participant
timeFrame: Discharge (about 3 months from birth)
measure: Length of participant
timeFrame: Discharge (about 3 months from birth)
measure: Head circumference of participant
timeFrame: Discharge (about 3 months from birth)
measure: Number of participants that die
timeFrame: Discharge (about 3 months from birth)
measure: Number of participants that die
timeFrame: at 2 years
measure: Number of participants that develop Neonatal Morbidity
timeFrame: Discharge (about 3 months from birth)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lindsay Holzapfel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: