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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOLE | Experimental |
| |
| MOLE | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants free of BPD (infants breathing in room air) | 36 weeks post menstrual age (PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in relative mole percentages of Docosahexaenoic acid (DHA) in plasma | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay F Holzapfel, MD, MS | Contact | (713) 500-6422 | Lindsay.N.Fleig@uth.tmc.edu | |
| Emily Stephens | Contact | (713) 500-5734 | Emily.K.Stephens@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Holzapfel, MD, MS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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 |
|
| baseline before LE exposure |
| Relative mole percentages of Docosahexaenoic acid (DHA) in plasma | end of the intervention period (28±3 postnatal days) |
| Relative mole percentages of Docosahexaenoic acid (DHA) in plasma | 36 weeks postmenstrual age (±3 days) |
| Change in relative mole percentages of Eicosapentaenoic acid (EPA) in plasma | 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 | baseline before LE exposure |
| Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma | end of the intervention period (28±3 postnatal days) |
| Relative mole percentages of Eicosapentaenoic acid (EPA) in plasma | 36 weeks postmenstrual age (±3 days) |
| Change in relative mole percentages of Arachidonic acid (ARA) in plasma | 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 | baseline before LE exposure |
| Relative mole percentages of Arachidonic acid (ARA) in plasma | end of the intervention period (28±3 postnatal days) |
| Relative mole percentages of Arachidonic acid (ARA) in plasma | 36 weeks postmenstrual age (±3 days) |
| Change in relative mole percentages of linoleic acid (LA) in plasma | 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 | baseline before LE exposure |
| Change in relative mole percentages of linoleic acid (LA) in plasma | end of the intervention period (28±3 postnatal days) |
| Change in relative mole percentages of linoleic acid (LA) in plasma | 36 weeks postmenstrual age (±3 days) |
| Change in Urine oxidative stress marker, superoxide dismutase | 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 | baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days) |
| Change in glutathione ratio | baseline before LE exposure, end of the intervention period (28±3 postnatal days), 36 weeks postmenstrual age (±3 days) |
| Amount of superoxide dismutase | baseline before LE exposure |
| Amount of superoxide dismutase | end of the intervention period (28±3 postnatal days) |
| Amount of superoxide dismutase | 36 weeks postmenstrual age (±3 days) |
| Glutathione ratio | baseline before LE exposure |
| Glutathione ratio | end of the intervention period (28±3 postnatal days) |
| Glutathione ratio | 36 weeks postmenstrual age (±3 days) |
| Amount of lipid peroxidase | baseline before LE exposure |
| Amount of lipid peroxidase | end of the intervention period (28±3 postnatal days) |
| Amount of lipid peroxidase | 36 weeks postmenstrual age (±3 days) |
| Change in lung reactance as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in resistance as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in impedance as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in resonance frequency as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in tidal volume as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in respiratory rate as assessed by the Non-Invasive Functional Oscillometry Test (FOT) | before discharge (~ 36 weeks post menstrual age), two years |
| Change in weight of participant | 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 | 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 | 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. | 2 years corrected age |
| Mechanical ventilation days | Discharge (about 3 months from birth) |
| Number of days participants are exposed to oxygen | Discharge (about 3 months from birth) |
| Number of chronic lung disease re-hospitalizations | after Neonatal Intensive Care Unit (NICU) discharge till 2 years of age |
| Number of participants that develop late onset sepsis | Discharge (about 3 months from birth) |
| Number of participants that develop cholestasis | Discharge (about 3 months from birth) |
| Weight of participant | Discharge (about 3 months from birth) |
| Length of participant | Discharge (about 3 months from birth) |
| Head circumference of participant | Discharge (about 3 months from birth) |
| Number of participants that die | Discharge (about 3 months from birth) |
| Number of participants that die | 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. | Discharge (about 3 months from birth) |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |