[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584441":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":28,"studyPopulation":22,"armGroups":29,"interventions":40,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":80,"collaborators":22,"id":83,"slug":22,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":22,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":22,"maxAge":90,"enrollmentInfo":91,"targetDuration":22,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":22,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Polish Mother Memorial Hospital Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Pain assessment pre and post intranasal midazolam administration","Primary Endpoint:\n\n\\- Change in the occurrence of pain symptoms and stress associated with screening ophthalmologic examination (ROP).\n\nUse of Premature Infant Pain Profile (PIPP) score\n\n* Purpose: To evaluate pain and stress responses before, during, and after the procedure.\n* Scoring Components:\n\n  * Heart rate changes.\n  * Oxygen saturation levels.\n  * Facial expressions (brow bulge, eye squeeze, nasolabial furrow).\n  * Behavioural state (awake, fussy, crying).\n  * Gestational age adjustment.","PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure",[14,18],{"measure":15,"description":16,"timeFrame":17},"Evaluation of clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomisation device) in newborns\u002Finfants.","To accurately report the adverse events during intranasal midazolam administration using a nasal atomizer (DART™ intranasal atomisation device) in newborns\u002Finfants, the Neonatal Adverse Event Severity Scale (NAESS) will be used.\n\nThis scale contains generic severity criteria that can occur in neonates, followed by a list of 35 specific medical conditions: neurological, cardiovascular, respiratory, gastrointestinal, infectious, general and any other symptoms\n\nEach of the criteria is divided into grading system:\n\nGrade 1 - Mild Grade 2 - Moderate Grade 3 - Severe Grade 4 - Life- threatening Grade 5 - Death Assessment of the severity of the adverse event is based on the observation of the changes in the following components: age appropriate behavioural changes, changes from the baseline in the vital signs, changes in the required care and monitoring. Only changes from the baseline condition will be considered as a reported adverse-events.","Neonatal Adverse Event Severity Scale (NAESS) will be reported up to 24 hours following drug administration.",{"measure":19,"description":20,"timeFrame":21},"Sedation assessment after intranasal midazolam administration.","To assess the sedation status after intranasal midazolam administration, Modified N-PASS: Neonatal Sedation Assessment Scale will be used.\n\nThe assessment criteria of the scale include:\n\n* Crying\u002F Irritability\n* Behaviour State\n* Facial Expression\n* Extremities Tone\n* Vital Signs: HR, RR, BP, SaO2 Each of the criteria scores from 0 to -2, the sum provides a total score and note as a negative score (0 to -10).\n\nDeep sedation: -10 to -6 Light sedation: -5 to - 2 Normal: -1 to +3","Modified N-PASS score used to assess level of sedation time points: 5 minutes before drug administration, during drug administration, 10, 30 minutess, 1 hour and 2 hours post - drug administration.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":6,"observationalModel":22,"timePerspective":22,"maskingInfo":26},"RANDOMIZED","PARALLEL",{"masking":27,"maskingDescription":22,"whoMasked":22},"NONE","The aim of this parallel, prospective, nonblinded randomised control trial is to assess the effectiveness and safety of intranasal midazolam administered before ROP screening using the DART™ intranasal atomization device in preterm newborns and infants.\n\nParticipants: Preterm newborns and infants eligible for routine ROP screening. Recruitment: Parental\u002Flegal guardian consent required before random assignment to either the study or control group.\n\nStudy Groups and Randomization:\n\nRandom Assignment: Block randomization will be used. • Sample Size: 40 newborns\u002Finfants (20 in control, 20 in study group).\n\nStudy intervention and monitoring:\n\n• Study Group (midazolam group) 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 minutes before screening.\n* Swaddling and placement under the radiant warmer.\n\nMonitoring:\n\n* Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination.\n* Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure.\n* Modified N-PASS scale to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure.\n\nControl Group (non-midazolam group)\n\n* No midazolam administered.\n* Comfort measures: 1 ml of 20% glucose solution orally with a pacifier 5 minutes before screening. Swaddling and placement under the radiant warmer.\n\nMonitoring:\n\n* Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination.\n* Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure.\n\nIn both groups, observations for:\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)\n* Infections \\& Sepsis (Confirmed or suspected based on clinical signs)\n\nStudy Outcome Assessment:\n\nChange in pain and stress symptoms during ROP screening, measured by the Premature Infant Pain Profile (PIPP).\n\nClinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomization device) in newborns\u002Finfants.\n\nAssessment of sedation post intranasal midazolam administration.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"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",[35],"Drug: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.",{"label":37,"type":38,"description":39,"interventionNames":22},"Control group","NO_INTERVENTION","Control Group (non-midazolam group)\n\n* No midazolam administered.\n* Routine comfort care",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"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)",[31],[47],"nasal midazolam",[49],{"name":50,"affiliation":51,"role":52},"Ewa Gulczyńska, Professor","Polish Mother's Health Center Institute","STUDY_CHAIR",[54],{"name":55,"role":56,"phone":57,"phoneExt":22,"email":58},"Agnieszka Nowacka, MSc","CONTACT","+48 607603226","agn.nowacka@gmail.com",[60],{"facility":61,"status":22,"city":62,"state":22,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Polish Mother's Health Center Institute Rzgowska 281\u002F289, 93-338 Lodz","Lodz","93-338","Poland","PL",{"type":67,"coordinates":68},"Point",[69,70],19.47395,51.77058,{"lat":70,"lon":69},[73,77],{"name":74,"role":56,"phone":75,"phoneExt":22,"email":76},"Agnieszka Nowacka, Lek. med.","+48607603226","agnieszka.nowacka@iczmp.edu.pl",{"name":78,"role":79,"phone":22,"phoneExt":22,"email":22},"Agnieszka Nowacka, Lek. med","PRINCIPAL_INVESTIGATOR",{"type":79,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Agnieszka Nowacka","Principal Investigator, Senior Assistant at Neonatology Department","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":92,"type":93},40,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99],"Drug Safety",[101,102,103],"intranasal midazolam","ROP screening","Premature infants","NOT_YET_RECRUITING","2025-03-16",{"date":107,"type":108},"2025-03-21","ACTUAL",{"date":110,"type":93},"2025-03-24",{"date":112,"type":93},"2025-07-06",{"name":5,"class":6},1]