Randomized Trial Comparing Mixed Oil vs Soybean Oil Lipid Infusions to Reduce Lung Disease and Improve Development in Extremely Preterm Infants

What this Trial Is About

This research aims to compare two types of lipid emulsionsmixed oil lipid emulsion MOLE and soybean oil-based lipid emulsion SOLEin extremely preterm infants to see which better reduces bronchopulmonary dysplasia BPD and improves neurodevelopmental outcomes. The study also investigates the infants fatty acid profiles and early biochemical markers of oxidative stress, along with survival without BPD and long-term health effects. Participants will be randomly assigned to receive either MOLE or SOLE, starting at 1 gkgday with gradual increases up to 3 gkgday as tolerated, guided by triglyceride levels. The intervention period lasts about 28 days postnatal, during which lipid emulsions are administered under medical supervision. The study includes follow-up assessments up to two years to evaluate pulmonary health, neonatal morbidity, growth, and neurodevelopment using the Bayley Scales of Infant Development Fourth Edition BSID-IV. Throughout the study, infants will be monitored for breathing status at 36 weeks post menstrual age, fatty acid levels in plasma at baseline, end of intervention, and 36 weeks, along with oxidative stress markers in urine. Additional evaluations include lung function tests before discharge and at two years, growth measurements, and hospitalizations related to lung disease. Researchers will also track mechanical ventilation days, oxygen exposure, neonatal morbidity, and mortality up to two years, providing a comprehensive view of the treatments impacts over time.

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