Comparing Dexmedetomidine and Midazolam Sedation to Shorten Breathing Tube Time in Very Preterm Infants Born Before 32 Weeks

What this Trial Is About

This research aims to compare two sedative treatments, dexmedetomidine and midazolam, for very preterm newborns born before 32 weeks who require invasive mechanical ventilation to support breathing. The study explores whether dexmedetomidine, which may have fewer side effects on breathing and brain health, can help these fragile infants be taken off the ventilator sooner compared to midazolam. The trial is designed to provide evidence on sedation quality and respiratory outcomes in neonatal intensive care units. Participants will be randomly assigned to one of two groups. One group receives dexmedetomidine through a continuous intravenous infusion, starting with a loading dose over 30 minutes followed by a maintenance dose adjusted by medical staff. The other group receives midazolam in a similar way, with a loading dose and maintenance infusion. Treatments will continue during the period of invasive mechanical ventilation until extubation. Vital signs and pain levels will be regularly monitored, and treatment doses adjusted to achieve the desired sedation level. During the study, data such as sedation quality, opioid use, timing and success of extubation, and any adverse events will be recorded. Follow-up includes a final visit when the child reaches about 2 years corrected age to assess growth, motor development, neurological status, and developmental milestones using a standardized questionnaire. The main measurement is the time from stopping sedation to extubation, with additional monitoring up to 24 months for health and survival outcomes.

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants