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)
Parallel
Rocuronium Bromide 10 MG/ML
DrugRocuronium 0.6 mg/kg IV, single dose, administered as a bolus after fentanyl 1 mcg/kg IV, approximately 60 seconds before laryngoscopy
Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
DrugFentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation in both groups.
First-attempt intubation success without physiological instability
Composite outcome defined as correct endotracheal tube placement on the first laryngoscopy attempt, confirmed by colorimetric CO2 detection, with no SpO2 drop greater than 20% from baseline and no bradycardia (heart rate below 100 bpm) of any duration. A new attempt is defined as removal and reinsertion of the laryngoscope blade into the oral cavity.
Total number of intubation attempts
Total number of laryngoscopy attempts required to achieve successful tracheal intubation, defined as each insertion of the laryngoscope blade into the oral cavity until its removal, regardless of tube insertion.
Procedure duration
Time in seconds from the first laryngoscopy attempt to confirmation of correct endotracheal tube position by colorimetric CO2 detection.
Severe oxygen desaturation
Occurrence of SpO2 drop greater than 20% from baseline value or SpO2 below 80%, at any point during the intubation procedure.
Bradycardia during intubation
Occurrence of heart rate below 100 bpm at any point during the intubation procedure.
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