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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
230
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
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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of participants free of BPD (infants breathing in room air)
Time frame: 36 weeks post menstrual age (PMA)
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)
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.
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)
Number of chronic lung disease re-hospitalizations
Time frame: 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)
Number of participants that develop cholestasis
Time frame: Discharge (about 3 months from birth)
Weight of participant
Time frame: Discharge (about 3 months from birth)
Length of participant
Time frame: Discharge (about 3 months from birth)
Head circumference of participant
Time frame: Discharge (about 3 months from birth)
Number of participants that die
Time frame: Discharge (about 3 months from birth)
Number of participants that die
Time frame: 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.
Time frame: Discharge (about 3 months from birth)
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