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Rocuronium and Fentanyl for Neonatal Intubation: A Randomized Clinical Trial (NEORIN) (NEORIN)

10. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

102

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate
  • Telefonnummer: +55 92981228890
  • E-post: jpguilherme@uea.edu.br

Studiesteder

  • Brasil
    • Amazonas
      • Manaus, Amazonas, Brasil, 69057000
        • Maternidade Ana Braga - UTI Neonatal
        • Ta kontakt med:
          • JEFFERSON PEREIRA GUILHERME, M.D.; PhD candidate
          • Telefonnummer: +55 92 981228890
          • E-post: jpguilherme@uea.edu.br

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Newborn admitted to the Neonatal ICU with postnatal age ≤28 days or corrected gestational age <44 weeks Clinical indication for non-emergent tracheal intubation, defined as a minimum interval of 5 minutes between the decision to intubate and the start of laryngoscopy Informed consent signed by legal guardian

Exclusion Criteria:

  • Emergency intubation (cardiac arrest, acute airway obstruction with rapidly progressive desaturation, or any situation where delay for premedication represents immediate risk to life) Known or suspected upper airway malformation (micrognathia, limited mouth opening or neck extension, cleft palate, cervical hemangioma or mass, or history of difficult intubation) Use of neuromuscular blocking agent within 24 hours prior to intubation Known hypersensitivity to fentanyl or rocuronium Severe hemodynamic instability (ongoing shock requiring fluid bolus or initiation of vasoactive drug within the preceding 2 hours) Cyanotic congenital heart disease with shunt dependency or critical instability Maternal chronic opioid use or active neonatal abstinence syndrome Simultaneous participation in another interventional clinical trial involving premedication or airway management Any situation in which the attending physician considers participation clinically unsafe

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fentanyl + Rocuronium
Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation.
Legemiddel: 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
Aktiv komparator: Fentanyl Only
Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.
Legemiddel: 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
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First-attempt intubation success without physiological instability
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total number of intubation attempts
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Sponsor

UEA - Universidade Do Estado Do Amazonas

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NEORIN-2026-MAB/UEA

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