Study of Low Versus High Flow Rates in High Flow Nasal Ventilation and Their Effect on Carbon Dioxide Levels in Preterm Infants

What this Trial Is About

Researchers are evaluating the effects of different flow rates of heated, humidified high-flow nasal ventilation HFNV on carbon dioxide levels in preterm infants born between 24 and 33.6 weeks gestation who require respiratory support. This study aims to compare low 2 liters per minute and high 6 liters per minute flow rates of HFNV to understand their impact on transcutaneous CO2 tcCO2 levels. The study is a prospective, crossover observational design conducted in a neonatal intensive care setting, focusing on respiratory distress in premature newborns. Participants will be randomly assigned to start with either 2 LPM or 6 LPM flow rates of HFNV. Each infant will be monitored over three hours with alternating flow rates to measure changes in tcCO2 and other respiratory parameters. The study will observe whether different flow rates cause significant changes in CO2 levels and will track any instances where safety limits for CO2 or oxygen saturation are exceeded. The study may stop early if unsafe conditions like severe desaturation or bradycardia occur. During the study, preterm infants will have their tcCO2 continuously monitored while undergoing HFNV at different flow settings. Researchers will collect data on respiratory function and safety indicators such as oxygen levels and heart rate. The primary outcome is the change in tcCO2 three hours after switching flow rates. Secondary outcomes include the number of study terminations due to unsafe CO2 levels or respiratory complications. The study plans to enroll 45 infants and will use statistical tests to analyze the results.

Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.