Fentanyl and Rocuronium for Tracheal Intubation in Newborns (NCT07650552) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Brazil102 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
1 Minute – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rocuronium and fentanyl together for intubating premature newborns — can you explain how using a muscle relaxant like rocuronium alongside a pain medication differs from how intubation is currently done in your unit, and what the potential risks of that combination are for a premature baby?
2Since this trial is Phase 4, does that mean rocuronium and fentanyl are already individually approved for use in newborns, and what do we know so far about their safety profile in premature infants specifically?
3The trial hasn't started recruiting yet — what is the current standard of care for intubating premature babies with respiratory distress syndrome or apnea of prematurity in your hospital, and would my baby receive that same care if we don't participate?
4The primary goal of this trial is to measure successful first-attempt intubation without causing physiological instability — can you help me understand what 'physiological instability' means for a premature baby during intubation, and why getting the tube in on the first try matters so much for their safety?
5Given that my baby is premature and already fragile, what are the risks of participating in a trial like this compared to just receiving whatever your NICU's current standard intubation protocol is?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First-attempt intubation success without physiological instability
Timeframe: During the intubation procedure, from first laryngoscopy attempt to confirmation of tube position (up to 5 minutes)
Trial details
NCT IDNCT07650552
SponsorUEA - Universidade Do Estado Do Amazonas
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-08
Contact for this trial
JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate