[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534348":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":54,"centralContacts":58,"locations":64,"responsibleParty":82,"collaborators":84,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 1",null,"To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation.\n\nThe aim is correlate the results from the bronchoscopy with the panel of test proposed, and evaluate if these simple bedside tests can pick up the same level of infection or inflammation and obtain the same results, as the bronchoscopy, which is a much more invasive test, but the only method available at present to get this information.",[13,14,15,16,17,18],"Procedure: Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy","Diagnostic Test: Skin prick test","Diagnostic Test: Finger prick blood test","Diagnostic Test: Forced oscillation technique (FOT)","Procedure: Sputum induction","Diagnostic Test: Oropharyngeal swab",{"label":20,"type":10,"description":21,"interventionNames":22},"Aim 2","The aim is to test how acceptable these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use.",[14,15,16,17,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Aim 3","Small proof-of-concept study. This is for a feasibility trial of using the proposed tests and deciding the treatment of their wheeze, based on the results of the tests. Children with evidence of allergen sensitisation +\u002F- blood eosinophilia (\\>0.3x109\u002FL) will be prescribed regular inhaled corticosteroids. Children who are non-atopic (non-atopic is defined as blood eosinophil of \\\u003C0.3x109\u002FL + no evidence of allergen sensitisation) with positive bacterial detection in sputum, will be prescribed four weeks of targeted antibiotics. Children who are non-atopic with no bacteria detected in sputum, will be prescribed only be prescribed short acting bronchodilators as required. All medications will be prescribed, as per the British National Formulary for Children, based on age and weight.\n\nThe aims of this preliminary study are to understand whether parents will agree to be part of such an interventional trial. This will help the research team when designing a future larger clinical trial.",[14,15,16,17,18],[28,33,38,42,46,50],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"PROCEDURE","Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy","These children who will be having a bronchoscopy (a long thin tube, with a camera at the end, which is put inside the lung to look at and collect samples) as part of their standard clinical management, determined by their own consultants or treating physicians. They will be having lung samples (washings from the lung and a tiny piece of tissue taken from the breathing tubes) taken as part of their usual medical management. The research team will ask for consent to use the leftover samples for the bronchoscopy, for the study",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"DIAGNOSTIC_TEST","Skin prick test","To identify children with allergies. This test will not be done if the child has had allergy testing in the last 6 months",[9,20,24],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Finger prick blood test","Finger prick testing will be used for blood samples, and it is the same technique used by children with diabetes, to test their blood sugar levels, and therefore is regularly used in this age group successfully. The research team will be obtain the results within minutes, using a point-of-care device. A few more drops of blood, from the same finger prick sample, will be taken to look at how one of the blood cells work, in more detail, in the laboratory. There is no additional finger prick required for this lab test, and the drops of blood will be collected at the same time, from the same prick, as the point of care test.",[9,20,24],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Forced oscillation technique (FOT)","Breathing test will be performed using forced oscillation technique (FOT), to see how the child's lungs work and to detect airway inflammation. The test will be explained to the child and completed using our established protocols. This test will only require the child to breathe in and out normally, and therefore can be done in preschool aged children. The current test that is used to check lung function called spirometry cannot be used in preschool children, as it involves following complicated instructions. The aim is to assess how well this newer lung function test is tolerated, in children aged 1-5 years.",[9,20,24],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Sputum induction","Sputum induction is a test of obtaining phlegm after inhalation of salt water mist (saline nebuliser) and this will allow the research team to look for any relationships between infection in the lungs and the accuracy of the less invasive, nose and throat swabs. The research team will obtain phlegm samples, with a quick suction after patients have inhaled the salty mist (saline nebuliser) which will help loosen up their phlegm. If the child can cough it up, they will be encouraged to do it.",[9,20,24],{"type":34,"name":51,"description":52,"armGroupLabels":53,"otherNames":10},"Oropharyngeal swab","Swabs from children's nose and throats (similar to swab tests that are done for Covid tests), that will be used to test for bacterial infection",[9,20,24],[55],{"name":56,"affiliation":5,"role":57},"Sejal Saglani, MD","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":10,"email":63},"Cheuk Fung Wong","CONTACT","+4420 7594 9832","cheuk-fung.wong@imperial.ac.uk",[65],{"facility":66,"status":67,"city":68,"state":10,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Royal Brompton Hospital","RECRUITING","London","SW3 6NP","United Kingdom","UK",{"type":73,"coordinates":74},"Point",[75,76],-0.12574,51.50853,{"lat":76,"lon":75},[79],{"name":80,"role":61,"phone":10,"phoneExt":10,"email":81},"Patrik Pettersson","p.pettersson@rbht.nhs.uk",{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[85,87,90],{"name":86,"class":6},"Action Medical Research",{"name":88,"class":89},"Masonic Charitable Foundation","UNKNOWN",{"name":91,"class":6},"Royal Brompton & Harefield NHS Foundation Trust","100534348","longitudinal-preschool-wheeze-biomarker-study-100534348",false,"NCT06237660","Longitudinal Preschool Wheeze Biomarker Study","Development of Non-invasive Biomarkers to Direct Individualised Management of Preschool Wheeze","Inclusion Criteria:\n\nAim 1, 2 and 3:\n\n* Children aged 1-5 years\n* More than 2 hospitalisations for acute wheeze in the last year or\n* At least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year.\n\nAim 1 only:\n\n\\- children undergoing clinically indicated bronchoscopy, as determined by their existing medical team, as part of their standard management\n\nExclusion Criteria:\n\n* Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis.","ALL","1 Year","5 Years",{"count":103,"type":104},150,"ESTIMATED","OBSERVATIONAL","Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child.\n\nThe goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group.\n\nThe research team would like to investigate the following aims:\n\nAim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation.\n\nAim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use.\n\nAim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child.\n\nThe panel of simple non-invasive tests that the research team are proposing are:\n\n1. Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds)\n2. Finger prick blood test\n3. Phlegm test for bacteria\n4. Nose and throat swab for bacteria\n5. Lung function test called forced oscillation technique (FOT)",[108],"Wheezing",[110,111,112,113,114],"Preschool wheeze","Preschool asthma","Allergy","Infection","Steroids","2024-04-26",{"date":117,"type":118},"2024-04-29","ACTUAL",{"date":120,"type":118},"2024-02-01",{"date":122,"type":104},"2026-08-31",{"name":5,"class":6},1]