[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tracheomalacia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tracheomalacia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100518292","dynamic-airway-ct-is-diagnostic-for-tracheomalacia-in-children-100518292",false,"NCT06028646","Dynamic Airway CT is Diagnostic for Tracheomalacia in Children","Inclusion Criteria:\n\n* Participants 0-18 years old, with\n* Clinically indicated flexible bronchoscopy has been performed\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Unable to undergo CT scanning without sedation\n* Patients with tracheostomy","ALL","0 Years","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this pilot interventional study is to evaluate the use of Dynamic Airway Computed Tomography (DA-CT) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. The primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of DA-CT as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. The results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of DA-CT diagnostic potential.",[26],"Tracheomalacia",[28],"Tracheomalacia in Children","RECRUITING","2024-09-25",{"date":32,"type":33},"2024-09-26","ACTUAL",{"date":35,"type":33},"2023-08-10",{"date":37,"type":20},"2025-06-30",{"name":39,"class":40},"NYU Langone Health","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100547540","phase-3-enhancing-lung-health-in-kids-with-structural-lung-damage-and-malformations-azithromycin-azi-for-airway-infection-prevention-100547540","NCT06409299","Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention","Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention","TRALULALA-AZI","Inclusion Criteria:\n\n1. CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations\n2. Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.\n3. At risk of or already documented respiratory infections requiring antibiotics.\n4. Age between 0-72 months at inclusion.\n\nExclusion Criteria:\n\n1. Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.\n2. Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.\n3. Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.\n4. Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.\n5. Neurological or psychiatric disorders\n6. Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.\n7. Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.\n8. Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.","0 Months","72 Months",{"count":52,"type":20},150,[54],"PHASE3","Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.\n\nThe link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.\n\nExperts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.\n\nTo address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.",[26,57,58,59,60,61],"Bronchopulmonary Dysplasia (BPD)","Vascular Ring","Cystic Lung Disease","Bronchiectasis","Chronic Atelectasis","NOT_YET_RECRUITING","2024-05-10",{"date":65,"type":33},"2024-05-14",{"date":67,"type":20},"2024-09-01",{"date":69,"type":20},"2027-08-31",{"name":71,"class":40},"Rigshospitalet, Denmark"]