Fentanyl and Rocuronium for Tracheal Intubation in Newborns

NCT07650552 | Not Yet Recruiting Phase 4

• 1 other identifier: NEORIN-2026-MAB/UEA
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature; Intubation, Intratracheal; Respiratory Distress Syndrome, Newborn; Apnea of Prematurity

Keywords

neonatal intubation; rocuronium; premedication; neuromuscular blocking agent; sugammadex; first-attempt success; NICU; newborn

Outcome Measures

Primary Outcomes (1)

• 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.

  During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)

Secondary Outcomes (7)

• Total number of intubation attempts

  During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)

• Procedure duration

  From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)

• Severe oxygen desaturation

  During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)

• Bradycardia during intubation

  During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)

• Need for additional maneuvers

  During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)

Study Arms (2)

Fentanyl + Rocuronium

EXPERIMENTAL

Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation.

Drug: Rocuronium Bromide 10 MG/ML

Fentanyl Only

ACTIVE COMPARATOR

Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.

Drug: Rocuronium Bromide 10 MG/ML; Drug: Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.

Interventions

Rocuronium Bromide 10 MG/ML DRUG

Rocuronium 0.6 mg/kg IV, single dose, administered as a bolus after fentanyl 1 mcg/kg IV, approximately 60 seconds before laryngoscopy

Fentanyl + Rocuronium; Fentanyl Only

Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. DRUG

Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation in both groups.

Fentanyl Only

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• UEA - Universidade Do Estado Do Amazonas: lead

Study Sites (1)

Maternidade Ana Braga - UTI Neonatal

Manaus, Amazonas, 69057000, Brazil

Location

Related Publications (5)

• 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.

  PMID: 30971749 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.

  PMID: 20966694 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.

  PMID: 29467520 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.

  PMID: 31563910 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.

  PMID: 30538147 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn; Apnea

Interventions

Rocuronium; Fentanyl

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate

CONTACT

+55 92981228890; jpguilherme@uea.edu.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Complete masking is not feasible because rocuronium produces clinically detectable neuromuscular blockade. Partial masking is adopted: the primary outcome assessor, who reviews video recordings, and the data analyst are blinded to group allocation. The intubating physician is aware of the allocated group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist; Coordinator of Pediatric Residency Program; PhD Candidate

Model Details: Two parallel groups with 1:1 allocation ratio. Intervention group receives fentanyl plus rocuronium; control group receives fentanyl

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)