Fentanyl and Rocuronium for Tracheal Intubation in Newborns

Summary

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.

Timeline

Start

2026-09

Primary completion

2028-08

Completion

2029-02

Publications

• Background Lin JD, Fang WF, Tang KT, Cheng CW. Effects of exogenous melatonin on clinical and pathological features of a human thyroglobulin-induced experimental autoimmune thyroiditis mouse model. Sci Rep. 2019 Apr 10;9(1):5886. doi: 10.1038/s41598-019-42442-0.
• Background Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
• Background Krick J, Gray M, Umoren R, Lee G, Sawyer T. Premedication with paralysis improves intubation success and decreases adverse events in very low birth weight infants: a prospective cohort study. J Perinatol. 2018 Jun;38(6):681-686. doi: 10.1038/s41372-018-0082-2. Epub 2018 Feb 21.
• Background Herrick HM, Glass KM, Johnston LC, Singh N, Shults J, Ades A, Nadkarni V, Nishisaki A, Foglia EE; for the NEAR4NEOS Investigators. Comparison of Neonatal Intubation Practice and Outcomes between the Neonatal Intensive Care Unit and Delivery Room. Neonatology. 2020;117(1):65-72. doi: 10.1159/000502611. Epub 2019 Sep 27.
• Background Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.

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