Dexmedetomidine versus Fentanyl for Sedation and Analgesia in Mechanically Ventilated Neonates A superiority parallel group open label randomized controlled trial

This study will compare dexmedetomidine and fentanyl for providing sedation and analgesia in neonates who require invasive mechanical ventilation. Neonates of gestational age 26 weeks or more who need continuous sedative or analgesic infusion will be enrolled after informed consent and randomized to receive either dexmedetomidine or fentanyl. Drug dosing, titration, rescue medication, and cessation will follow standardized protocols. Sedation and analgesia will be assessed using the N PASS score, and vital signs including heart rate, blood pressure, respiratory rate, and oxygen saturation will be monitored regularly. The primary outcome is the total duration of sedative or analgesic infusion, measured from initiation of drug infusion until its final discontinuation and will be analyzed as a time to event variable with censoring for death or maximum follow up of 28 days. Secondary outcomes include cumulative rescue fentanyl use, duration of mechanical ventilation, length of NICU stay, achievement and maintenance of target sedation without treatment failure, incidence of withdrawal assessed by modified Finnegan scoring, and adverse effects such as bradycardia, hypotension, desaturation, and agitation. The study will follow neonates through the index episode of ventilation until extubation, drug discontinuation, or 44 weeks postmenstrual age.