[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601587":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":26,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":92,"overallStatus":109,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"IWK Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Fentanyl Group","EXPERIMENTAL","Participants in this group will receive intranasal fentanyl at a dose of 2 mcg\u002Fkg administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening. The study drug will be delivered via a mucosal atomization device into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.",[13],"Drug: Fentanyl Citrate (Intranasal)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants in this group will receive an equivalent volume of intranasal 0.9% normal saline placebo administered 10 minutes prior to initiation of retinopathy of prematurity (ROP) screening using a mucosal atomization device. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.",[19],"Drug: Normal Saline (Placebo, Intranasal)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fentanyl Citrate (Intranasal)","Fentanyl citrate will be administered intranasally at a dose of 2 mcg\u002Fkg via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. The intervention will be delivered into one nostril. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline (Placebo, Intranasal)","An equivalent volume of intranasal 0.9% normal saline placebo will be administered via a mucosal atomization device 10 minutes prior to retinopathy of prematurity (ROP) screening. All participants will also receive standard comfort measures as part of routine NICU care, including oral sucrose, non-nutritive sucking, swaddling, and topical anesthetic eye drops.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Helen McCord, BScN, MN, PhD Candidate, NNP","CONTACT","19024971412","mccordhelen@hotmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"IWK Health","Halifax","Nova Scotia","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-63.57688,44.64269,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":36},"Helen McCord","9024971412",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Marsha Campbell-Yeo","Clinician Scientist, Neonatal Nurse Practitioner, Professor",[59,62,64],{"name":60,"class":61},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":63,"class":6},"Dalhousie University",{"name":5,"class":6},"100601587","phase-1-fentanyl-intranasal-for-retinopathy-of-prematurity-screening-in-preterm-infants-100601587",false,"NCT07112430","Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants","Intranasal Fentanyl to Reduce Pain Intensity Associated With Retinopathy of Prematurity Screening in Preterm Infants: A Randomized Control Trial","FIREFLY","Inclusion Criteria\n\n* Preterm infants born ≤31 weeks gestational age and\u002For with birth weight \\\u003C1250 g\n* Scheduled to undergo routine retinopathy of prematurity (ROP) screening as part of standard NICU care\n* Clinically stable at the time of screening, defined as not requiring acute resuscitative support (no bag-mask ventilation, intubation, or chest compressions within the preceding 24 hours) and maintaining stable cardiorespiratory parameters on baseline respiratory support\n* Written informed consent obtained from a parent or legally authorized representative\n\nExclusion Criteria\n\n* Congenital anomalies or conditions affecting the nasal passages that would interfere with intranasal drug administration\n* Receipt of systemic opioids, benzodiazepines, barbiturates, or other sedative\u002Fanalgesic medications within 24 hours prior to the ROP examination\n* Known hypersensitivity or prior adverse reaction to fentanyl","ALL",{"count":75,"type":76},58,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening.\n\nParticipants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.",[83,84,85,86,87,88,89,90,91],"Neonatal Pain","Retinopathy of Prematurity (ROP)","Pain Management","Infant, Premature","Fentanyl","Infant, Newborn","Neonatal Intensive Care Units","Analgesia","Intranasal Drug Administration",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"intranasal fentanyl","fentanyl","neonatal analgesia","procedural pain","ROP screening","Retinopathy of Prematurity","Preterm infants","Premature infants","infant pain","Non-invasive analgesia","Opioid analgesia","Intranasal drug delivery","Neonatal intensive care","NICU","Pain management in neonates","Infant procedural sedation","NOT_YET_RECRUITING","2026-06-26",{"date":112,"type":113},"2026-06-30","ACTUAL",{"date":115,"type":76},"2026-09-09",{"date":117,"type":76},"2028-06-01",{"name":56,"class":6},1]