A Phase 4 interventional study of Rocuronium Bromide 10 MG/ML and Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation. in Infant, Premature, Intubation, Intratracheal and Respiratory Distress Syndrome, Newborn, sponsored by UEA - Universidade Do Estado Do Amazonas. Not yet recruiting at 1 site in Brazil. Open to participants aged 1 Minute to 28 Days. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by UEA - Universidade Do Estado Do Amazonas · Phase 4, Interventional, and Treatment
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.
Neonatal tracheal intubation is performed in approximately 15-20% of NICU admissions. First-attempt success rates are approximately 49%, and adverse tracheal intubation-associated events (TIAEs) occur in up to 18% of procedures, with severe oxygen desaturation in up to 48% (NEAR4NEOS registry, Foglia et al., 2019). Premedication with neuromuscular blocking agents has been independently associated with a 62% reduction in adverse events (aOR 0.38; 95% CI 0.25-0.57).
Rocuronium is a non-depolarizing neuromuscular blocking agent with rapid onset, stable hemodynamic profile, and full reversibility with sugammadex, making it a safe choice for neonatal premedication.
The NEORIN trial will enroll 102 newborns (51 per group) with postnatal age ≤28 days or corrected gestational age \<44 weeks, requiring non-emergent tracheal intubation. Randomization will be performed in variable-sized permuted blocks (4 and 6), with allocation concealment through sequential opaque sealed envelopes.
Intervention group: fentanyl 1 mcg/kg IV + rocuronium 0.6 mg/kg IV. Control group: fentanyl 1 mcg/kg IV + saline placebo (equivalent volume). Sugammadex is available at the bedside throughout the study as a mandatory safety requirement.
The primary composite outcome is first-attempt intubation success without physiological instability, defined as correct tube placement on the first laryngoscopy attempt confirmed by colorimetric CO2 detection, with no SpO2 drop >20% from baseline and no bradycardia (HR \<100 bpm). All procedures will be video-recorded for blinded outcome assessment.
A secondary descriptive study will assess neonatologists' and residents' knowledge of and barriers to neuromuscular blocking agent use in neonatal intubation, using a structured questionnaire applied before the start of the clinical trial.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 102 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with UEA - Universidade Do Estado Do Amazonas as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
Drug page: Rocuronium
Rocuronium 0.6 mg/kg IV, single dose, administered as a bolus after fentanyl 1 mcg/kg IV, approximately 60 seconds before laryngoscopy
Drug page: Fentanyl
Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation in both groups.
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.
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Total number of intubation attempts
Total number of laryngoscopy attempts required to achieve successful tracheal intubation, defined as each insertion of the laryngoscope blade into the oral cavity until its removal, regardless of tube insertion.
Time frame: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Procedure duration
Time in seconds from the first laryngoscopy attempt to confirmation of correct endotracheal tube position by colorimetric CO2 detection.
Time frame: From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)
Severe oxygen desaturation
Occurrence of SpO2 drop greater than 20% from baseline value or SpO2 below 80%, at any point during the intubation procedure.
Time frame: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Bradycardia during intubation
Occurrence of heart rate below 100 bpm at any point during the intubation procedure.
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Need for additional maneuvers
Need for any additional maneuver during intubation, including external laryngeal manipulation, blade change, stylet use, or change of intubating physician.
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Medication-related adverse events
Occurrence of adverse events related to study medications, including hypotension, chest wall rigidity, allergic reactions, or need for sugammadex due to prolonged neuromuscular blockade.
Time frame: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Knowledge and barriers to neuromuscular blocking agent use
Score on a structured questionnaire assessing neonatologists' and residents' knowledge, attitudes, and barriers to the use of neuromuscular blocking agents in neonatal tracheal intubation. Applied as a descriptive cross-sectional sub-study before the start of the clinical trial.
Time frame: At the time of enrollment, before the intubation procedure, assessed once per participant
Plan to share: No
Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.
Of 54 non-industry phase 4 interventional studies under Premature Birth, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 23 months is close to that.
Counting every sponsor, half of 54 studies reached it within 25 months; a quarter within 13 and three quarters within 60.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rocuronium