[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581802":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":19,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":19,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":96,"whyStopped":19,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Premature babies: Study Intervention","EXPERIMENTAL","Preterm infants born at gestational age less than 29 0\u002F7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 7 days post-intervention)",[13,14],"Drug: Calfactant","Drug: Budesonide",{"label":16,"type":17,"description":18,"interventionNames":19},"Premature babies: Standard of Care","NO_INTERVENTION","Preterm infants born at gestational age less than 29 0\u002F7 weeks requiring mechanical ventilation at 7-14 days of life (targeting N=12 participants completing study to 10 days post-randomization)",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DRUG","Calfactant","Participants will receive 2 daily doses of Calfactant (3 ml\u002Fkg) intratracheal administration",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Budesonide","Participants will receive 2 daily doses of Budesonide (0.25mg\u002Fkg) intratracheal administration.",[9],[31],{"name":32,"affiliation":5,"role":33},"Dinushan Kaluarachchi, MBBS","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":19,"email":38},"CONTACT","(608) 417-6849","kaluarachchi@pediatrics.wisc.edu",{"name":40,"role":36,"phone":19,"phoneExt":19,"email":41},"Meg Baker","meg.baker@wisc.edu",[43,60],{"facility":44,"status":19,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Meriter Hospital","Madison","Wisconsin","53715","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-89.40123,43.07305,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":59,"phoneExt":19,"email":38},"Dinushan Kaluarachchi","608-417-6849",{"facility":61,"status":19,"city":45,"state":46,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"American Family Children's Hospital","53792",{"type":51,"coordinates":64},[53,54],{"lat":54,"lon":53},[67],{"name":32,"role":36,"phone":59,"phoneExt":19,"email":38},{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[71],{"name":72,"class":6},"Meriter Foundation","100581802","phase-1-little-lungs-study-100581802",false,"NCT06855043","Little Lungs Study","Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia","Neonate Inclusion Criteria:\n\n* Gestational age 22 0\u002F7 to 28 6\u002F7 weeks at birth\n* Age 7-14 days\n* Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3\n\nBirthing Parent Inclusion Criteria:\n\n* Have a baby who meets neonate eligibility criteria and enrolls in the study.\n\nNeonate Exclusion Criteria:\n\n* Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and\u002For genetic disorders\n* Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.)\n* History of pulmonary hemorrhage\n* Antibiotic use within 48 hours\n* Indomethacin or Ibuprofen use within 72 hours\n* Prior treatment with corticosteroids for prevention of lung disease\n* Not expected to survive for greater than 7 days at enrollment\n* Determined to be unstable by the clinical team\n* Enrolled in a conflicting clinical trial\n* Have a birth parent aged less than 18 years\n* Parent\u002Fguardian is unable to provide parental permission in English or Spanish","ALL","7 Days","14 Days",{"count":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88,89],"PHASE1","PHASE2","This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.",[92,93],"Invasive Mechanical Ventilation","Severe Respiratory Distress Syndrome",[95],"premature birth","NOT_YET_RECRUITING","2026-01-23",{"date":99,"type":100},"2026-01-27","ACTUAL",{"date":102,"type":85},"2026-09",{"date":104,"type":85},"2029-03",{"name":5,"class":6},2]