Bronchopulmonary Dysplasia, Neurodevelopmental Impairment
Conditions
Keywords
soybean oil-based lipid emulsion (SOLE), mixed oil lipid emulsion (MOLE)
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
Interventions
DRUGSOLE
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
DRUGMOLE
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 28 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants free of BPD (infants breathing in room air) | 36 weeks post menstrual age (PMA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline before LE exposure | — |
| 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 | — |
| 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 | — |
| 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 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 | — |
| Glutathione ratio | baseline before LE exposure | — |
| Amount of lipid peroxidase | baseline before LE exposure | — |
| 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) | 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. |
| 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 develop Neonatal Morbidity | 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. |
Countries
United States
Contacts
CONTACTLindsay F Holzapfel, MD, MS
CONTACTEmily Stephens
PRINCIPAL_INVESTIGATORLindsay Holzapfel, MD, MS
The University of Texas Health Science Center, Houston
Outcome results
None listed