[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607597":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":64,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":30,"maxAge":74,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":30,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"intravenous group","ACTIVE_COMPARATOR","this group of neonates will recieve intravenous fentanyl during procedure",[13],"Drug: fentanyl intravenous",{"label":15,"type":10,"description":16,"interventionNames":17},"direct intranasal group","this group of neonates will recieve direct intranasal fentanyl during procedure",[18],"Drug: fentanyl intranasal direct",{"label":20,"type":10,"description":21,"interventionNames":22},"nasal atomizer group","this group of neonates will recieve intranasal fentanyl with atomizer during procedure",[23],"Drug: Fentanyl intranasal using atomizer",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","fentanyl intravenous","giving intravenous fentanyl",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Fentanyl intranasal using atomizer","giving intranasal fentanyl using nasal atomizer",[20],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"fentanyl intranasal direct","giving intranasal fentanyl directly into nostrils",[15],[40],{"name":41,"affiliation":42,"role":43},"Passant Fahmy, M.Sc","Assisstant lecturer","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Passant Osama Fahmy, M.Sc","CONTACT","01066724641","Passant.Osama@med.asu.edu.eg",{"name":51,"role":47,"phone":30,"phoneExt":30,"email":30},"Rabab Gameel Allam, MD",[53],{"facility":5,"status":54,"city":55,"state":30,"zip":30,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":30},"RECRUITING","Cairo","Egypt","EG",{"type":59,"coordinates":60},"Point",[61,62],31.24967,30.06263,{"lat":62,"lon":61},{"type":65,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100607597","early-phase-1-intranasal-versus-intravenous-fentanyl-for-procedural-analgesia-in-preterm-neonates-100607597",false,"NCT07190625","Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates","Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm neonates with gestational age between 28 and 36 weeks gestation.\n* Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture.\n\nExclusion Criteria:\n\n* known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.\n* Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)\n* Post-surgical patients.\n* Patients sedated by fentanyl infusion \u002F midazolam infusion.\n* Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.","ALL","28 Days",{"count":76,"type":77},75,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management.\n\nUsing intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.",[83],"Procedural Pain","2025-09-26",{"date":86,"type":87},"2025-10-01","ACTUAL",{"date":89,"type":87},"2023-12-24",{"date":91,"type":77},"2026-06-01",{"name":5,"class":6},1]