[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561367":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":33,"locations":42,"responsibleParty":65,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":18,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":18,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ciclesonide","EXPERIMENTAL","Eligible infants will be approached by study team. Parents whose infants consent to the study drug will enter the dose-escalation part of the study. Inhaled Alvesco will be administered daily for 14 days at escalating doses 80mcg and 160mcg.",[13],"Drug: Alvesco Inhalant Product",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Eligible infants will be approached by study team. Parents who refuse consent to the study drug will have standard of care. These parents can accept for their infant's de-identified clinical data to be used as part of the control group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Alvesco Inhalant Product","Inhaled Alvesco will be administered daily for 14 days at escalating doses of 80mcg and 160mcg.",[9],[26],"ciclesonide",[28,31],{"name":29,"affiliation":5,"role":30},"Venkatesh Sampath, MD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":32,"role":30},"Physician-Scientist",[34,38],{"name":29,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","816-234-3596","vsampath@cmh.edu",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Miah R Ruffin, BA, CCRC","816-731-7443","mrruffin@cmh.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Children's Mercy Kansas City","RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-94.57857,39.09973,{"lat":55,"lon":54},[58,61],{"name":29,"role":35,"phone":59,"phoneExt":60,"email":37},"816-802-1177","78167",{"name":62,"role":35,"phone":63,"phoneExt":18,"email":64},"Mariana Theodoro, MD","816-234-3591","mftheodoro@cmh.edu",{"type":66,"investigatorFullName":67,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Venkatesh Sampath",[69,71],{"name":70,"class":6},"University of Pittsburgh",{"name":72,"class":73},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100561367","phase-1-inhaled-ciclesonide-study-in-preterm-infants-100561367",false,"NCT06589245","Inhaled Ciclesonide Study in Preterm Infants","The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n* Viable Infants born between 23 0\u002F7 - 29 6\u002F7 gestation\n* Requiring invasive (through an endotracheal tube) mechanical ventilation\n* Between day of life 8 to 35.\n* Infants have not received dexamethasone for 120 hours\n* If receiving hydrocortisone, then receiving ≤ 1mg\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.\n* Infants receiving DEX therapy will be excluded.\n* We will exclude infants who have had ≥ 1 glucose level \\> 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (\\>95% centile for gestational age) in the 48 hours prior to study entry.\n* For small for gestational age, we will exclude infants with a birthweight \\\u003C 5% centile for gestational age.\n* Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.\n* Infants receiving or have received any dexamethasone in the prior 120 hours.\n* Infants receiving \\>1mg\u002Fkg\u002Fday of hydrocortisone.\n* Infants receiving any other inhaled or systemic steroid.","ALL","8 Days","35 Days",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).",[92],"Bronchopulmonary Dysplasia","2026-03-26",{"date":95,"type":96},"2026-03-27","ACTUAL",{"date":98,"type":96},"2025-09-16",{"date":100,"type":86},"2026-08-31",{"name":67,"class":6},1]