[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542429":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":54,"centralContacts":62,"locations":70,"responsibleParty":88,"collaborators":10,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University Hospital, Antwerp","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Preterm infants",null,"all included infants will undergo a breath test and two throat swabs, in case the infant is intubated also endotracheal aspirates will be collected",[13,14,15],"Diagnostic Test: Breath test","Other: Throat swabs","Other: Endotracheal aspirates",{"label":17,"type":10,"description":18,"interventionNames":19},"Mothers of preterm infants","placental biopsies, a placental swab and a vaginal swab will be taken after birth",[20,21],"Other: Placental samples","Other: Vaginal swab",[23,33,37,44,48],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","Breath test","Early detection of volatile organic compounds (VOCs) in breath from preterm infants, collected at several timepoints within the first 4 weeks of life to predict BPD before diagnosis is made at 36 weeks PMA.",[9],[29,30,31,32],"Exhaled breath analysis","Volatomics","Exhaled Volatile Organic Compounds","Exhaled VOCs",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Throat swabs","A throat swab will be taken on several timepoints within the first 4 weeks of life to detect airway mucin expression. A second throat swab will be taken as proxy for the airway microbiome.",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placental samples","After birth, placental biopsies will be collected for headspace VOCs analysis. A placental swab and a biopsy will be taken for microbiome analysis.",[17],[42,43],"Placental headspace VOCs analysis","Placental swabs",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"Vaginal swab","A vaginal swab will be taken before birth for microbiome analysis.",[17],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Endotracheal aspirates","Collection of aspirates, as part of routine care, to detect mucin expression and the lung microbiome.",[9],[53],"Aspirates",[55,59],{"name":56,"affiliation":57,"role":58},"Antonius Mulder, MD, PhD,prof","University Hospital Antwerp, Belgium","PRINCIPAL_INVESTIGATOR",{"name":60,"affiliation":57,"role":61},"Stijn L Verhulst, MD, PhD,prof","STUDY_DIRECTOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":10,"email":67},"Inès Ghys, MD","CONTACT","+3232655230","ines.ghys@uantwerpen.be",{"name":69,"role":65,"phone":10,"phoneExt":10,"email":10},"Kristien Vanhaverbeke, MD, PhD",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University Hospital Antwerp","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":80,"coordinates":81},"Point",[82,83],4.44504,51.15662,{"lat":83,"lon":82},[86],{"name":87,"role":65,"phone":10,"phoneExt":10,"email":67},"Inès Ghys",{"type":89,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100542429","the-role-of-volatile-organic-compounds-vocs-airway-mucins-and-the-microbiome-in-the-early-prediction-of-bronchopulmonary-dysplasia-bpd-100542429",false,"NCT06342752","The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)","The Role of Volatile Organic Compounds (VOCs), Airway Mucins and Microbiome in the Development of Bronchopulmonary Dysplasia and the Feasibility of Exhaled Breath VOCs Analysis as an Early Detection Tool","INFANCY","Inclusion Criteria:\n\n* Born at a gestational age \\\u003C 30 weeks\n\nExclusion Criteria:\n\n* Major congenital defect or disorder\n* Patients with an unstable general condition as deemed by the attending neonatologist",true,"ALL","0 Days","3 Days",{"count":103,"type":104},140,"ESTIMATED","OBSERVATIONAL","Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.\n\nDespite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.\n\nSecondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.\n\nThirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.\n\nThe threefold aim of this study is as follows:\n\nI. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.\n\nII. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.\n\nIII. The detection of potential alterations in airway mucin expression in BPD patients.\n\nThrough this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.\n\nIn total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included.",[108],"Bronchopulmonary Dysplasia",[110,111,112,113,29,114,115,116,117,118,119],"Volatile Organic Compounds","Preterm birth","Airway microbiome","Airway mucins","Placental microbiome","Vaginal microbiome","Early prediction of BPD","Inflammation Lungs","Respiratory morbidity","multiple breath washout test","2025-05-05",{"date":122,"type":123},"2025-05-09","ACTUAL",{"date":125,"type":123},"2024-06-14",{"date":127,"type":104},"2027-09",{"name":5,"class":6},1]