[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584441":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":59,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Polish Mother Memorial Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal midazolam and comfort care","EXPERIMENTAL","The newborn\u002Finfant qualified for the ROP screening will receive intranasal midazolam before the procedure using a nasal atomizer.\n\nThe newborn\u002Finfant will also receive comfort care",[13],"Drug: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Control Group (non-midazolam group)\n\n* No midazolam administered.\n* Routine comfort care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.","Intervention: Intranasal midazolam (0.2 mg\u002Fkg) administered 10 minutes before ROP screening via the DART™ intranasal atomization device.\n\nComfort Measures:\n\n* 1 ml of 20% glucose solution orally with a pacifier, 5 min before screening.\n* Swaddling and placement under the radiant warmer.\n\nMonitoring:\n\n* Vital Signs (heart rate, respiratory rate, blood pressure, oxygen saturation monitoring before drug administration until 2 hours after).\n* Pain assessment (PIPP scale) conducted before, during, and 10 and 30 min post-procedure.\n* Modified N-PASS to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure\n\nObservations for signs of:\n\n* Respiratory Distress (apnoea, desaturation, increased work of breathing)\n* Cardiovascular Instability (Bradycardia, tachycardia, hypotension)\n* Neurological Symptoms (Lethargy, seizures, abnormal tone)\n* Gastrointestinal Issues (Feeding intolerance, NEC-like symptoms)",[9],[26],"nasal midazolam",[28],{"name":29,"affiliation":30,"role":31},"Ewa Gulczyńska, Professor","Polish Mother's Health Center Institute","STUDY_CHAIR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Agnieszka Nowacka, MSc","CONTACT","+48 607603226","agn.nowacka@gmail.com",[39],{"facility":40,"status":18,"city":41,"state":18,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Polish Mother's Health Center Institute Rzgowska 281\u002F289, 93-338 Lodz","Lodz","93-338","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],19.47395,51.77058,{"lat":49,"lon":48},[52,56],{"name":53,"role":35,"phone":54,"phoneExt":18,"email":55},"Agnieszka Nowacka, Lek. med.","+48607603226","agnieszka.nowacka@iczmp.edu.pl",{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Agnieszka Nowacka, Lek. med","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Agnieszka Nowacka","Principal Investigator, Senior Assistant at Neonatology Department","100584441","phase-1-use-of-intranasal-midazolam-to-reduce-stress-and-procedural-pain-in-premature-infants-during-routine-rop-examination-100584441",false,"NCT06889376","Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.","The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening","Inclusion Criteria:\n\n* Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):\n\n  a. Newborns\u002Finfants born before the 32 weeks of gestation and\u002For with a birth weight \\\u003C1500 g.\n* Obtaining informed consent from a parent\u002Flegal guardian.\n\nExclusion Criteria:\n\n* Newborns\u002Finfants not qualified for screening ophthalmologic examination (ROP).\n* Newborns\u002Finfants clinically unstable, with respiratory disorders\u002Fcardiovascular instability before the ophthalmologic examination.\n* Newborns\u002Finfants with congenital developmental defects.\n* Newborns\u002Finfants receiving analgesic\u002Fsedative medications for other reasons.","ALL","30 Weeks",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.\n\nThe main question it aims to answer is:\n\n• Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening?\n\nResearchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.",[79],"Drug Safety",[81,82,83],"intranasal midazolam","ROP screening","Premature infants","NOT_YET_RECRUITING","2025-03-16",{"date":87,"type":88},"2025-03-21","ACTUAL",{"date":90,"type":73},"2025-03-24",{"date":92,"type":73},"2025-07-06",{"name":5,"class":6},1]