[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642471":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"UEA - Universidade Do Estado Do Amazonas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fentanyl + Rocuronium","EXPERIMENTAL","Fentanyl 1 mcg\u002Fkg IV followed by rocuronium 0.6 mg\u002Fkg IV, administered sequentially before non-emergent tracheal intubation.",[13],"Drug: Rocuronium Bromide 10 MG\u002FML",{"label":15,"type":16,"description":17,"interventionNames":18},"Fentanyl Only","ACTIVE_COMPARATOR","Fentanyl 1 mcg\u002Fkg IV administered before non-emergent tracheal intubation, without neuromuscular blocking agent.",[13,19],"Drug: Fentanyl 1 mcg\u002Fkg IV, single dose, administered before non-emergent tracheal intubation.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rocuronium Bromide 10 MG\u002FML","Rocuronium 0.6 mg\u002Fkg IV, single dose, administered as a bolus after fentanyl 1 mcg\u002Fkg IV, approximately 60 seconds before laryngoscopy",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Fentanyl 1 mcg\u002Fkg IV, single dose, administered before non-emergent tracheal intubation.","Fentanyl 1 mcg\u002Fkg IV, single dose, administered before non-emergent tracheal intubation in both groups.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"JEFFERSON PEREIRA GUILHERME, M.D., Ph.D. candidate","CONTACT","+55 92981228890","jpguilherme@uea.edu.br",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Maternidade Ana Braga - UTI Neonatal","Manaus","Amazonas","69057000","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-60.025,-3.10194,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"JEFFERSON PEREIRA GUILHERME, M.D.; PhD candidate","+55 92 981228890",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jefferson Pereira Guilherme","Neonatologist; Coordinator of Pediatric Residency Program; PhD Candidate","100642471","phase-4-fentanyl-and-rocuronium-for-tracheal-intubation-in-newborns-100642471",false,"NCT07650552","Fentanyl and Rocuronium for Tracheal Intubation in Newborns","Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial","NEORIN","Inclusion Criteria:\n\n* Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age \\\u003C44 weeks\n* Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)\n* Informed consent signed by legal guardians\n\nExclusion Criteria:\n\n* Upper airway malformations\n* Use of neuromuscular blocking agent in the 24 hours prior to enrollment\n* Known hypersensitivity to fentanyl or rocuronium\n* Severe hemodynamic instability (ongoing shock)\n* Anticipated difficult airway (micrognathia, cleft palate, or similar)\n* Cyanotic congenital heart disease with critical instability\n* Neonatal abstinence syndrome\n* Concurrent enrollment in another interventional clinical trial","ALL","1 Minute","28 Days",{"count":71,"type":72},102,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","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.\n\nThis randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg\u002Fkg IV) to standard fentanyl premedication (1 mcg\u002Fkg 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\u002Fkg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.\n\nA secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.",[78,79,80,81],"Infant, Premature","Intubation, Intratracheal","Respiratory Distress Syndrome, Newborn","Apnea of Prematurity",[83,84,85,86,87,88,89,90],"neonatal intubation","rocuronium","premedication","neuromuscular blocking agent","sugammadex","first-attempt success","NICU","newborn","NOT_YET_RECRUITING","2026-06-29",{"date":94,"type":95},"2026-07-01","ACTUAL",{"date":97,"type":72},"2026-09",{"date":99,"type":72},"2029-02",{"name":5,"class":6},1]