[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521312":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine","ACTIVE_COMPARATOR","Intranasal Dexmedetomidine 2 microgram\u002Fkilogram, 30 minutes before eye examination",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination",[19],"Drug: Saline",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Saline","Intranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Sagee Nissimov, MD","CONTACT","97289779080","sageen@shamir.gov.il",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Iris Morag, MD","97289778286","IRISMO@shamir.gov.il",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Be’er Ya‘aqov","Center","7033001","Israel","IL",{"type":49,"coordinates":50},"Point",[51,52],34.83749,31.93864,{"lat":52,"lon":51},[55,56,57,59],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":58,"role":33,"phone":25,"phoneExt":25,"email":25},"Sigal Zmujack-Yehiam, MD",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sagee Nissimov","Principal Investigator","100521312","phase-3-intranasal-dexmedetomidine-for-pain-management-during-screening-for-retinopathy-of-prematurity-100521312",false,"NCT06067958","Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity","Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial","Inclusion Criteria:\n\n* Gestational age \\\u003C 31 weeks post-menstrual age, or birth weight \\\u003C 1500 grams\n* Informed consent signed by one of the parents\n\nExclusion Criteria:\n\n* Invasive ventilation at the time of the eye assessment\n* Multiple congenital anomalies\n* Chromosomal \u002F genetic anomalies\n* Infant received a sedative drug in last 5 days\n* Eye examination for reasons other than retinopathy of prematurity screening\n* Attending physician deemed the patient not stable enough","ALL","4 Weeks",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed \"retinopathy of prematurity\". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.\n\nPurpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.\n\nThe main questions it aims to answer are:\n\n* Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).\n* Does dexmedetomidine cause more adverse effects than placebo.\n\nIn this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.",[81,9],"Retinopathy of Prematurity",[81,9,83,84,85],"Pain","Analgesia","Premature Infant Pain Profile - Revised","2024-12-04",{"date":88,"type":89},"2024-12-06","ACTUAL",{"date":91,"type":89},"2023-12-11",{"date":93,"type":75},"2025-12",{"name":5,"class":6},1]