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

2026년 6월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

102

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate
  • 전화번호: +55 92981228890
  • 이메일: jpguilherme@uea.edu.br

연구 장소

  • 브라질
    • Amazonas
      • Manaus, Amazonas, 브라질, 69057000
        • Maternidade Ana Braga - UTI Neonatal
        • 연락하다:
          • JEFFERSON PEREIRA GUILHERME, M.D.; PhD candidate
          • 전화번호: +55 92 981228890
          • 이메일: jpguilherme@uea.edu.br

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Fentanyl + Rocuronium
Fentanyl 1 mcg/kg IV followed by rocuronium 0.6 mg/kg IV, administered sequentially before non-emergent tracheal intubation.
의약품: 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
활성 비교기: Fentanyl Only
Fentanyl 1 mcg/kg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.
의약품: 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
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
First-attempt intubation success without physiological instability
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Total number of intubation attempts
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UEA - Universidade Do Estado Do Amazonas

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 8월 1일

연구 완료 (추정된)

2029년 2월 1일

연구 등록 날짜

최초 제출

2026년 6월 10일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NEORIN-2026-MAB/UEA

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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