Fentanyl and Rocuronium for Tracheal Intubation in Newborns

Starting soon · Phase 4

Conditions studied: Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity

In brief

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.

Key facts

Study ID

NCT07650552

Run by

UEA - Universidade Do Estado Do Amazonas

People needed

102

Starts

2026-09-01

Expected to finish

2029-02-01

Last updated by the study team

2026-07-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Anticipated difficult airway (micrognathia, cleft palate, or similar)
• Cyanotic congenital heart disease with critical instability
• Neonatal abstinence syndrome
• Concurrent enrollment in another interventional clinical trial

Where it is running

• Maternidade Ana Braga - UTI Neonatal — Manaus, Amazonas, Brazil

Full record on ClinicalTrials.gov

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