[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581802":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":67,"collaborators":69,"id":72,"slug":19,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":19,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":19,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":94,"whyStopped":19,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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",[43,59],{"facility":44,"status":19,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Meriter Hospital","Madison","Wisconsin","53715","United States",{"type":50,"coordinates":51},"Point",[52,53],-89.40123,43.07305,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":19,"email":38},"Dinushan Kaluarachchi","608-417-6849",{"facility":60,"status":19,"city":45,"state":46,"zip":61,"country":48,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"American Family Children's Hospital","53792",{"type":50,"coordinates":63},[52,53],{"lat":53,"lon":52},[66],{"name":32,"role":36,"phone":58,"phoneExt":19,"email":38},{"type":68,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[70],{"name":71,"class":6},"Meriter Foundation","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":82,"type":83},24,"ESTIMATED","INTERVENTIONAL",[86,87],"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.",[90,91],"Invasive Mechanical Ventilation","Severe Respiratory Distress Syndrome",[93],"premature birth","NOT_YET_RECRUITING","2026-01-23",{"date":97,"type":98},"2026-01-27","ACTUAL",{"date":100,"type":83},"2026-09",{"date":102,"type":83},"2029-03",{"name":5,"class":6},2]