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Fentanyl and Rocuronium for Tracheal Intubation in Newborns (NEORIN)

29 juin 2026 mis à jour par: Jefferson Pereira Guilherme, UEA - Universidade Do Estado Do Amazonas

Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

102

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate
  • Numéro de téléphone: +55 92981228890
  • E-mail: jpguilherme@uea.edu.br

Lieux d'étude

  • Brésil
    • Amazonas
      • Manaus, Amazonas, Brésil, 69057000
        • Maternidade Ana Braga - UTI Neonatal
        • Contact:
          • JEFFERSON PEREIRA GUILHERME, M.D.; PhD candidate
          • Numéro de téléphone: +55 92 981228890
          • E-mail: jpguilherme@uea.edu.br

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fentanyl + Rocuronium
Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation.
Médicament: 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
Comparateur actif: Fentanyl Only
Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.
Médicament: 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
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
First-attempt intubation success without physiological instability
Délai: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total number of intubation attempts
Délai: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
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.
During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Procedure duration
Délai: From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)
Time in seconds from the first laryngoscopy attempt to confirmation of correct endotracheal tube position by colorimetric CO2 detection.
From first laryngoscopy attempt to confirmation of endotracheal tube position, assessed during the intubation procedure (up to 5 minutes)
Severe oxygen desaturation
Délai: During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Occurrence of SpO2 drop greater than 20% from baseline value or SpO2 below 80%, at any point during the intubation procedure.
During the intubation procedure, from first laryngoscopy attempt to successful intubation (up to 5 minutes)
Bradycardia during intubation
Délai: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Occurrence of heart rate below 100 bpm at any point during the intubation procedure.
During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Need for additional maneuvers
Délai: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Need for any additional maneuver during intubation, including external laryngeal manipulation, blade change, stylet use, or change of intubating physician.
During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Medication-related adverse events
Délai: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Occurrence of adverse events related to study medications, including hypotension, chest wall rigidity, allergic reactions, or need for sugammadex due to prolonged neuromuscular blockade.
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
Délai: At the time of enrollment, before the intubation procedure, assessed once per participant
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.
At the time of enrollment, before the intubation procedure, assessed once per participant

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

UEA - Universidade Do Estado Do Amazonas

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 février 2029

Dates d'inscription aux études

Première soumission

10 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

16 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NEORIN-2026-MAB/UEA

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

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