Ongoing Clinical Trials for Infant Sedation
Currently, there is 1 ongoing clinical trial investigating sedation approaches for very preterm infants who require mechanical ventilation. This trial is being conducted in France and compares two different sedative medications to determine which is safer and more effective for helping these fragile newborns transition off breathing support.
Clinical trial locations
Study on Sedation Effects of Dexmedetomidine vs. Midazolam in Mechanically Ventilated Preterm Infants
This clinical trial focuses on very preterm infants—babies born before 32 weeks of pregnancy—who need help breathing through a machine called a ventilator. These tiny babies often need sedation to keep them comfortable and calm while on the ventilator. The study compares two sedative medications, dexmedetomidine and midazolam, to see which one works better and is safer for these vulnerable infants.
Main inclusion criteria: To participate in this study, infants must be admitted to a neonatal intensive care unit (NICU) and born at less than 32 weeks of pregnancy. Their corrected age must be less than 45 weeks (counting from the mother’s last menstrual period). The babies must need sedation for mechanical breathing support, and the decision to sedate should allow enough time to prepare. They should have or be getting a venous line (a small tube in a vein to give medications), and there should be no medical reasons that would make using dexmedetomidine or midazolam unsafe.
Main exclusion criteria: Infants cannot join the study if they are receiving certain muscle-relaxing medications (curare agents), if they had their breathing tube removed within the past 7 days, if they are on a medication called Clonidine, if their blood pressure and circulation are unstable, or if they are receiving palliative care (comfort care for serious illness).
Focus and goal: The primary goal is to measure how long it takes for infants to have their breathing tube safely removed (extubation) after stopping the sedative medication. Researchers will also monitor for side effects such as slow heart rate or low oxygen levels, check whether the babies need additional pain relief, and assess their comfort levels using a special scoring system. The study aims to identify which sedative is more effective at helping these preterm babies transition off mechanical ventilation safely and comfortably.
Investigational drugs: The two medications being tested are dexmedetomidine and midazolam. Dexmedetomidine works by activating specific receptors in the body that reduce stress hormone release, leading to sedation. Midazolam is a benzodiazepine that enhances the calming effects of a natural brain chemical called GABA. Both medications are given through an intravenous line (directly into the bloodstream). The trial will help determine which medication allows for quicker and safer removal of breathing support while keeping the infant comfortable.
The trial is expected to run until December 2028, with recruitment beginning in September 2024. This research could provide valuable information to improve care for very preterm infants who need mechanical ventilation.
Summary
This single ongoing trial in France addresses an important question in neonatal intensive care: how to best sedate very preterm infants on mechanical ventilation. The study’s focus on comparing dexmedetomidine and midazolam could help doctors choose the safest and most effective sedation approach for these fragile newborns. The trial’s emphasis on measuring time to extubation and monitoring for side effects reflects a careful, patient-centered approach to improving outcomes for preterm infants who require breathing support.
