[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493158":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":73,"collaborators":12,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":12,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":58,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Conservative arm","NO_INTERVENTION","Children assigned to this treatment arm will be conservatively managed, and will continue to be followed until the age of 5 years (end of study inclusion).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Surgical arm","ACTIVE_COMPARATOR","Children assigned to this treatment arm will undergo elective surgical resection at the age of 6-9 months, and will continue to be followed until the age of 5 years (end of study inclusion).",[18],"Procedure: Elective surgical resection of CPAM between 6 and 9 months of age",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"PROCEDURE","Elective surgical resection of CPAM between 6 and 9 months of age","Surgical resection of the CPAM between 6 and 9 months of age",[14],[26],{"name":27,"affiliation":28,"role":29},"Rene MH Wijnen, professor","Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"J Marco Schnater, MD, PhD","CONTACT","0031 107036923","j.schnater@erasmusmc.nl",{"name":27,"role":33,"phone":34,"phoneExt":12,"email":37},"r.wijnen@erasmusmc.nl",[39,56],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Radboud University Medical Centre","NOT_YET_RECRUITING","Nijmegen","Gelderlanf","6525GA","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],5.85278,51.8425,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":12,"phoneExt":12,"email":12},"Maarten Schurink, MD, PhD",{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Erasmus MC Sophia Children's Hospital","RECRUITING","Rotterdam","South Holland","3015GD",{"type":48,"coordinates":63},[64,65],4.47917,51.9225,{"lat":65,"lon":64},[68,71],{"name":69,"role":33,"phone":70,"phoneExt":12,"email":35},"Marco Schnater, MD, PhD","0031107036923",{"name":72,"role":33,"phone":70,"phoneExt":12,"email":37},"Rene MH Wijnen, Professor",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","dr. J Marco Schnater","dr. J.M. Schnater, Principal Investigator","100493158","the-collaborative-neonatal-network-for-the-first-cpam-trial-100493158",false,"NCT05701514","The COllaborative Neonatal Network for the First CPAM Trial","The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial","CONNECT","Inclusion Criteria:\n\n* Lesion detected during routine prenatal ultrasound screening\n* Delivery at term: gestational age ≥37 weeks\n* Birthweight \\> -2SD or \\>P10\n* Asymptomatic at birth defined as no prolonged respiratory distress or oxygen support (\\\u003C 24 hours)\n* Asymptomatic up to the moment of inclusion\n* Confirmation of CPAM on postnatal chest CT-scan at 3-9 months of age, according to structured report form (34)\n* Unilateral lesion occupying no more than one lung lobe as assessed on chest CT-scan at 3-9 months of age\n\nExclusion Criteria:\n\n* Bilateral lesion\n* Development of symptoms before randomization, considered by treating physician as caused by CPAM with reasonable certainty\n* Complicated pregnancy defined as (pre-)eclampsia, pregnancy diabetes in mother, foetal hydrops or severe polyhydramnios on prenatal ultrasound\n* Syndrome associated anomalies on genetic analysis confirmed by genetic expert\n* Major associated malformations. Anomalies include cardiac malformations requiring surgical correction or follow-up by a paediatric cardiologist, congenital malformations requiring major surgical intervention, and anomalies that affect normal lung growth and development.\n* Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months\n* Participation in another randomised controlled trial","ALL","1 Month","1 Year",{"count":89,"type":90},176,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this clinical trial is to compare conservative wait-and-see management to elective surgical intervention, in asymptomatic Congenital Pulmonary Airway Malformation (CPAM) children.\n\nChildren assigned to the intervention group will undergo surgical resection of the CPAM between 6 and 9 months of age. Children assigned to the control group will be monitored conservatively. The follow-up scheme will be uniform for both treatment groups and last for 5 years.\n\nThe primary outcome is the difference in maximal endurance at five years of age between the surgical and conservative group. Secondary outcome measures are molecular genetic diagnostics, validated questionnaires - on parental anxiety, quality of life and health care consumption -, repeated imaging, and pulmonary morbidity during follow-up, as well as surgical complications and histopathology.",[96],"Congenital Pulmonary Airway Malformation",[98,99,100,101],"Asymptomatic CPAM","Optimal management","Conservative vs surgical","Randomized","2024-03-01",{"date":104,"type":105},"2024-03-04","ACTUAL",{"date":107,"type":105},"2023-01-01",{"date":109,"type":90},"2030-12-31",{"name":5,"class":6},2]