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Fentanyl and Rocuronium for Tracheal Intubation in Newborns

NCT07650552 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

DRUG

Rocuronium Bromide 10 MG/ML

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

DRUG

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

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

Sponsors & Collaborators

  • UEA - Universidade Do Estado Do Amazonas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-08-31
Completion
2029-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650552 on ClinicalTrials.gov