Fentanyl and Rocuronium for Tracheal Intubation in Newborns

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.

NCT Number	NCT07650552
Lead Sponsor	UEA - Universidade Do Estado Do Amazonas
Conditions	Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
Enrollment	102 participants
Start Date	2026-09
Primary Completion	2028-08 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-01