Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.
This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.
A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.
Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <44 weeks
Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)
Informed consent signed by legal guardians
Upper airway malformations
Use of neuromuscular blocking agent in the 24 hours prior to enrollment
Known hypersensitivity to fentanyl or rocuronium
Severe hemodynamic instability (ongoing shock)