[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wheezing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wheezing":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,52,81,106,134,176,193,230,259,292,313,332,357,384,406,432],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100540001","early-life-intervention-in-pediatrics-supported-by-e-health---smoke-100540001",false,"NCT06311162","Early Life Intervention in Pediatrics Supported by E-health - SMOKE","Early Life Intervention in Pediatrics Supported by E-health (ELIPSE II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial","ELIPSE-II","Inclusion Criteria:\n\n* Age: younger than 6 years\n* Exposed to second-hand smoke at home (at least one parent smoking)\n* German speaking parent\n* All sex and ethnic backgrounds\n* Signed informed consent form from parent\n* Children live\u002Fgrow-up in the same household as the parental participant\n* Referred by a health care professional (e.g. physician, midwife, nurse, other professions)\n\nExclusion Criteria:\n\n* Participation in another study\u002Ftrial targeting similar outcomes\n* Participation in an active smoking cessation programme",true,"ALL","5 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"NA","Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .",[28,29,30,31,32,33],"Smoking Reduction","Asthma in Children","Wheezing","Non-Communicable Disease","Life Style","Behavior, Smoking",[35,36,37,38],"Secondhand smoke","Children","Prevention","eHealth","RECRUITING","2026-04-30",{"date":42,"type":43},"2026-05-06","ACTUAL",{"date":45,"type":43},"2024-05-07",{"date":47,"type":22},"2028-12-31",{"name":49,"class":50},"Insel Gruppe AG, University Hospital Bern","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100324531","swiss-paediatric-airway-cohort-100324531","NCT03505216","Swiss Paediatric Airway Cohort","SPAC","Inclusion Criteria:\n\n* Children and adolescents aged 0-16 years\n* Resident in Switzerland\n* Seen in a paediatric pulmonary outpatient clinic due to respiratory problems\n* Parents and patients above age 14 must be able to sign an informed consent form\n\nExclusion Criteria:\n\nPrior diagnosis of cystic fibrosis, primary ciliary dyskinesia, severe heart disease, oncological disease, neuromuscular disease or severe disability","0 Years","16 Years",{"count":62,"type":22},6000,"OBSERVATIONAL","The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits.\n\nCurrently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled.\n\nSPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies.\n\nPublications and plain language summaries are listed on the study website: https:\u002F\u002Fwww.spac-study.ch\u002Fpublikationen\u002F",[66,30,67,68,69,70],"Asthma","Cough","Exercise Induced Bronchospasm","Inspiratory Laryngeal Obstruction","Dysfunctional Breathing","2026-04-16",{"date":73,"type":43},"2026-04-21",{"date":75,"type":43},"2017-06-06",{"date":77,"type":22},"2030-06-01",{"name":79,"class":50},"University of Bern",12,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":88,"maxAge":19,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100530786","phase-3-efficacy-and-safety-of-subcutaneous-dupilumab-in-participants-with-asthmaasthmatic-wheeze-aged-2-to-6-years-liberty-asthma-trekids-100530786","NCT06191315","Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma\u002FAsthmatic Wheeze Aged 2 to \u003C6 Years (LIBERTY ASTHMA TREKIDS)","A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to \u003C6 Years of Age With Uncontrolled Asthma and\u002For Recurrent Severe Asthmatic Wheeze","Inclusion Criteria:\n\n* Participant must be 2 to \\\u003C6 years of age\n* Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and\u002For recurrent severe asthmatic wheeze.\n* At least one additional major criterion from the modified asthma predictive index:\n\n  1. Physician diagnosed Atopic Dermatitis,\n  2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU\u002FL).\n\n     OR 2 minor criteria:\n  3. Wheezing unrelated to colds,\n  4. Peripheral blood eosinophilia ≥4%,\n  5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE \\>0.35 kU\u002FL.\n* Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) willing and able to comply with clinic visits and study-related procedures.\n* Parent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) able to understand the study requirements.\n* Participants\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires\n* Body weight at screening and randomization \\>5 kg and \\\u003C30 kg.\n* Parents or caregivers or legal guardian capable of giving signed informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Severe asthma with the need for chronic oral\u002Fsystemic corticosteroid use (\\>1 month continuous) at the time of screening enrollment.\n* History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.\n* History of prematurity (\\\u003C34 weeks gestation).\n* Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.\n* History of life-threatening asthma (eg, requiring intubation).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","2 Years",{"count":90,"type":22},90,[92],"PHASE3","This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \\\u003C6 years of age with uncontrolled asthma and\u002For recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \\\u003C6 years old with uncontrolled asthma and\u002For recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.\n\nStudy details include:\n\nPart A:\n\nThe study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).\n\nPart B:\n\nFor participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \\[4-week Screening and a 52-week treatment period\\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).",[30,66],"2026-03-19",{"date":97,"type":43},"2026-03-20",{"date":99,"type":43},"2024-01-03",{"date":101,"type":22},"2028-12-21",{"name":103,"class":104},"Sanofi","INDUSTRY",74,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":133},"100490559","phase-2-soy-isoflavones-for-inner-city-infants-at-risk-for-asthma-sira-study-100490559","NCT05667701","Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study","SIRA","Inclusion Criteria:\n\n1. Parent\u002Fguardian must be an adult (≥18 years of age) and able to understand and provide informed consent.\n2. Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment\n3. High risk of asthma: As determined by one or more of the following:\n\n   1. A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR\n   2. Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR\n   3. atopic dermatitis in the child determined by parent report of a physician diagnosis\n4. Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).\n5. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).\n\n   1. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.\n\nExclusion Criteria:\n\n1. 1\\. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol.\n2. Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water).\n3. Currently on a soy based formula.\n4. Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding.\n5. On treatment for recurrent wheezing such as regular inhaled steroids.\n6. The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).\n7. Medication use\n\n   1. Maternal use of tamoxifen in pregnancy or if breastfeeding\n   2. Use of immunomodulatory medications such at methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.\n8. Use of another investigational agent in the last 30 days prior to randomization.\n9. Current, parent reported, diagnosis of mental illness or current, diagnosed or self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.\n10. Known allergy to soy protein (either by reported allergy or skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded.\n11. The infant is currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment.\n12. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n13. Infant requiring intubation prior to screening.\n14. Infant requiring \\> 3 hospitalizations for asthma symptoms\u002F wheezing illness prior to screening.\n15. Infant requiring \\> 3 five day bursts of oral steroid at least 14 days apart from each other prior to screening.\n16. Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or before randomization, and during the course of the study.\n17. Non-adherence:\n\n    1. Inability \u002F unwillingness of the parents to induce the infant to swallow study medication\n    2. Unwillingness of the parents to allow the staff to perform baseline measurements\n18. Living with a foster parent as a ward of the state.\n19. Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires).\n20. Plan(s) for the family to move from the area during the study period.\n21. The infant's caretaker does not primarily speak English or Spanish.\n\nIn order to be eligible to continue in the study following screening visit A (V1) , an individual must meet all of the following additional randomization criteria:\n\n1. Must be ≥4 months and \\\u003C12 months of age at randomization\n2. Must have either 4G\u002F4G or 4G\u002F5G genotype\n3. Cannot have had a severe wheezing exacerbation requiring ICU admission between screening (V1) and randomization (V3)\n4. Cannot have had more than two wheezing \u002F \"asthma\" episodes (separated from each other by at least 14 days), each requiring at least a 5 day course of oral steroids in the time between screening visit A (V1) and randomization (V3).","2 Months","12 Months",{"count":116,"type":22},65,[118],"PHASE2","The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.",[30,29],[122,123,124],"wheezing","soy isoflavone","PAI-1","2025-11-18",{"date":127,"type":43},"2025-11-21",{"date":129,"type":43},"2024-09-18",{"date":47,"type":22},{"name":132,"class":50},"Rajesh Kumar",2,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":17,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":159,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":51},"100559957","phase-3-vitamin-d-in-pregnancy-for-prevention-of-early-childhood-asthma-100559957","NCT06570889","VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma","VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)","VICTORY","* Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids\n* No current vitamin D intake above the recommended 400 IU\u002Fday\n* No endocrine-, heart-, kidney- or auto-immune disorders\n* No disorders requiring treatment with blood thinning medication","FEMALE","18 Years","45 Years",{"count":146,"type":22},2000,[92],"The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma\u002Fpersistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.",[66,150,151,152,153,154,30,155,156,157,158],"Respiratory Tract Infections","Gastrointestinal Infection","Croup","Eczema","Allergy","Fractures, Bone","Development, Child","Cognition Disorders in Children","Psychiatric Diagnosis",[160,66,161,153,154,162,163,164,165,166],"Childhood","Infections","Development","Psychiatry","Bone development","Cognition","Growth","2025-09-24",{"date":169,"type":43},"2025-09-30",{"date":171,"type":43},"2024-12-20",{"date":173,"type":22},"2033-03",{"name":175,"class":50},"Professor Klaus Bønnelykke",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":17,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":192,"locationsCount":51},"100559140","phase-3-fish-oil-in-pregnancy-for-personalized-prevention-of-early-childhood-asthma-100559140","NCT06560255","Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma","Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma (FREYA)","FREYA","* Pregnant Danish women before week 26 with blood levels of EPA+DHA below 4.7% of total fatty acids\n* No planned use of fish oil supplementations\n* No endocrine-, heart-, kidney- or auto-immune disorders\n* No disorders requiring treatment with blood thinning medication",{"count":146,"type":22},[92],"The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma\u002Fpersistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.",[66,150,151,152,153,154,30,155,156,157,158],[160,66,161,153,154,162,163,164,165,166],{"date":169,"type":43},{"date":171,"type":43},{"date":173,"type":22},{"name":175,"class":50},{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":51},"100596336","validate-the-efficacy-and-the-safety-of-the-keikku-electronic-stethoscope-for-its-indication-and-intended-purpose-under-the-intended-conditions-of-use-100596336","NCT07044128","Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.","Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope","KCI-1","Inclusion Criteria:\n\n* Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.\n* Individuals who are either:\n\n  * presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or\n  * presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or\n  * undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or\n  * undergoing non-urgent cardiac clearance in inpatient setting.\n\nExclusion Criteria:\n\npregnant female individuals","99 Years",{"count":203,"type":22},149,"This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use.\n\nThe study will include 149 participants of all ages (from birth to 99 years), who are undergoing routine (non-urgent) heart checks. After giving consent, each participant will have their heart sounds listened to twice: once with the Keikku electronic stethoscope and once with a regular stethoscope. Two different doctors will do the listening, and they won't share information with each other. The doctors will record whether they hear a heart murmur and how clear the sounds were.\n\nThe study will compare the findings from the new device to those from the regular stethoscope. Researchers will also check for any device problems or side effects. The study takes place at a single site in Peru and will take about one day for each participant.\n\nThe goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.",[206,30],"Heart Murmurs",[208,206,209,210,211,212,213,214,215,216,217,218,219,220],"Stethoscopes","Cardiac Auscultation","Diagnostic Techniques and Procedures","Medical Device Evaluation","Sound Recording and Reproduction","Pediatric Cardiology","Adult Cardiology","Telemedicine","Signal Processing, Computer-Assisted","Electronic Health Records","Clinical Accuracy","Safety Assessment","Prospective Studies","2025-06-23",{"date":223,"type":43},"2025-06-29",{"date":225,"type":22},"2025-07-15",{"date":227,"type":22},"2025-10-15",{"name":229,"class":104},"Lapsi Health Holding B.V.",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":17,"sex":18,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":51},"100560703","precision-medicine-directed-corticosteroids-in-children-with-preschool-wheeze-100560703","NCT06580600","PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze","A Single Centre Randomised, Feasibility Study Using Point-of-care (POC) Testing for Respiratory Viruses to Direct Oral Corticosteroids Use in Preschool-aged Children With Acute Wheeze.","PRECISE","Inclusion Criteria:\n\n* 24-60 months (infants from 24 months +0 days to 60 months + 0 days inclusive)\n* Clinical diagnosis of acute wheeze\n* Clinical uncertainty regarding the benefit of OCS as part of patient's standard care\n\nExclusion Criteria:\n\n* Signs and symptoms of severe or life-threatening wheeze\n* Patients presenting with wheeze suspicious for a non - respiratory cause\n* Clinical evidence of shock or bacterial sepsis\n* Past history of severe or life-threatening asthma or history of previous PICU admission with acute wheeze\n* History of preterm birth (before 36+0 weeks gestation)\n* Known immunodeficiency\u002Fongoing immunosuppressive therapy\n* Contraindication to oral corticosteroids\n* Previously enrolled in the PRECISE Study","24 Months","60 Months",{"count":241,"type":22},120,[25],"Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold. Wheeze can be treated with inhaled medications and sometimes oral steroid medicines are also given to reduce swelling within the lungs. Unfortunately, oral steroids can have side effects. Despite lots of research there is no clear evidence that oral steroids work in young children with a wheeze attack. It is likely that some children get better quicker with oral steroids but deciding who to treat is difficult. This results in differences in care with some children receiving unnecessary oral steroids and others not receiving them when they could benefit.\n\nThe investigators hypothesise that in a subgroup of children with mild-to-moderate acute wheeze attacks, the viral trigger can predict their response to steroid medications. Previously, respiratory virus testing was too slow to be used to inform treatments in the ED. Now, point-of-care (POC) viral tests can provide results within 30 minutes. There is a research gap regarding the role of these tests in determining steroid responsiveness and outcomes in children presenting with acute wheeze in the pre-school population.\n\nIn order to address the hypothesis in a future definitive trial, the feasibility of using (POC) viral tests to randomise steroid treatments for children in a clinical study in the ED setting must be ascertained. The PRECISE Study will therefore be a single centre randomised, feasibility study enrolling approximately 60 pre-school aged children to inform a future definitive multi-centre Randomised Controlled Trial.",[30],[246,247,248,249],"pre-school","wheeze","corticosteroid","point-of-care","2025-03-18",{"date":252,"type":43},"2025-03-21",{"date":254,"type":43},"2024-11-04",{"date":256,"type":22},"2025-12-03",{"name":258,"class":50},"Queen's University, Belfast",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":18,"minAge":267,"maxAge":60,"enrollmentInfo":268,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":133},"100524278","vitamin-c-to-decrease-effects-of-smoking-in-pregnancy-on-infant-lung-function-vcsip-longer-term-follow-up-100524278","NCT06106646","Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up","Assessing the Effect of Vitamin C on Infant Lung Function When Given to Pregnant Women Who Smoke - (Long Term Follow-up of a Randomized Trial)","VCSIP","Inclusion Criteria:\n\n* Women and their offspring randomized to vitamin C versus placebo during pregnancy as well as pregnant nonsmokers and their offspring enrolled as the reference group in the original VCSIP study\n\nExclusion Criteria:\n\n* participants who specifically withdraw consent","6 Years",{"count":269,"type":22},225,"The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's airway function tests. The investigators aim to demonstrate sustained improvement in airway\u002Fpulmonary function and trajectory through 10 years of age.",[66,272,30,273],"Pulmonary Function","In Utero Nicotine",[66,272,275,276,277,278,279,280,281,282,283],"Pulmonary Function Testing","Wheeze","Vitamin C","Antioxidants","Forced Expiratory Flows","Spirometry","Lung Function","Epigenetics","High resolution CT scans","2025-03-17",{"date":250,"type":43},{"date":287,"type":43},"2023-10-11",{"date":289,"type":22},"2028-08",{"name":291,"class":50},"Oregon Health and Science University",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":18,"minAge":299,"maxAge":238,"enrollmentInfo":300,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":51},"100523248","video-assisted-study-of-salbutamol-response-in-viral-wheezing-100523248","NCT06093152","Video Assisted Study of Salbutamol Response in Viral Wheezing","ViVi","Inclusion Criteria:\n\n* Wheezing\n* Salbutamol-treatment in emergency department prescribed\n\nExclusion Criteria:\n\n* Need for immediate resuscitation\n* Immediate transfer to ICU\n* Suspicion of pneumonia based on the auscultation finding\n* Suspicion of airway foreign body","6 Months",{"count":301,"type":22},50,"The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.",[30],"2025-02-11",{"date":306,"type":43},"2025-02-13",{"date":308,"type":43},"2023-10-23",{"date":310,"type":22},"2026-12",{"name":312,"class":50},"University of Oulu",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":18,"minAge":88,"maxAge":267,"enrollmentInfo":319,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":51},"100562470","phenotypes-of-preschool-wheezing-among-children-attending-sohag-university-hospital-100562470","NCT06603584","Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital","Inclusion Criteria:\n\n* patients from the age of one to five years with recurrent wheezing\n\nExclusion Criteria:\n\n* Children above 5 years and below one year old.\n* Failure to obtain informed consent.\n* Children below 6 years with chest diseases other than wheezing",{"count":320,"type":22},100,"Wheezing in preschool children is very common, with a wide differential diagnosis. It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making wheeze one of the commonest respiratory symptoms.The differential diagnosis of wheeze is wide, and different management strategies are needed depending on the underlying phenotype. The word 'wheeze' is used to describe many different sounds. That can be heard by both clincians and parent. Even if true wheeze is heard, this should not be automatically assumed to be due to bronchospasm. Airway narrowing by mucus will produce true wheeze but does not respond to bronchodilators. Similarly, airway malacia, either related to intrinsic airway wall defects or loss of alveolar tethering points, are also causes of bronchodilatorunresponsive wheeze; indeed, bronchodilators, by reducing airway smooth muscle tone, may actually worsen airway narrowing.",[30],"2024-09-17",{"date":325,"type":43},"2024-09-19",{"date":327,"type":43},"2024-06-04",{"date":329,"type":22},"2025-04-04",{"name":331,"class":50},"Sohag University",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":18,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":51},"100444109","phase-3-protecting-preterm-infants-from-respiratory-tract-infections-and-wheeze-by-using-bacterial-lysates-100444109","NCT05063149","Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.","Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.","PROTEA","Inclusion Criteria:\n\n* Gestational age at delivery between 30+0 and 35+6 weeks\n* Postnatal age at least 6 weeks at randomization \\& postmenstrual age at least 37 weeks\n* Written informed consent by both parents or formal caregivers\n\nExclusion Criteria:\n\n* Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.\n* Lower RTI before randomization\n* Dysmaturity and\u002For weight \\\u003C 2.5 kg at age of randomization.\n* Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and\u002For breastfeeding\n* Parents unable to speak and read Dutch\u002FEnglish language\n* Known allergic hypersensitivity to the active ingredients\u002Fsubstance or to any of the excipients.","6 Weeks","10 Weeks",{"count":343,"type":22},500,[92],"The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.",[30,347,348],"LRTI","Premature","2024-08-20",{"date":351,"type":43},"2024-08-22",{"date":353,"type":43},"2022-01-18",{"date":310,"type":22},{"name":356,"class":50},"Franciscus Gasthuis",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":18,"minAge":363,"maxAge":143,"enrollmentInfo":364,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":51},"100531568","prospective-multicentre-study-on-symptoms-in-first-onset-bronchial-asthma-in-children-and-adolescents-100531568","NCT06201494","Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents","Inclusion Criteria:\n\n\\- Child 3 - 18 years old, first evaluation in pulmonary outpatient clinic for any of the following respiratory symptoms: cough, shortness of breath, chest tightness, wheezing, recurrent lower respiratory tract and lung infections, dyspnoea of any type, pathological listening findings.\n\nExclusion Criteria:\n\n* Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.","3 Years",{"count":365,"type":22},80,"Bronchial asthma may present with symptoms other than the commonly reported complaints (cough, chest tightness, shortness of breath and wheezing). Less common symptoms include chronic or recurrent productive cough, inspiratory dyspnoea or recurrent pneumonia. Children presenting with these symptoms are often diagnosed with asthma bronchiale and benefit from antiasthmatic management.",[66,29,368,67,369,30,370,371,372,373,374],"Dyspnea","Pneumonia","Shortness of Breath","Chest Tightness","Lower Respiratory Tract and Lung Infections","Recurrent Respiratory Tract Infections","Mucus; Plug","2024-06-14",{"date":377,"type":43},"2024-06-18",{"date":379,"type":43},"2023-01-01",{"date":381,"type":22},"2026-06-01",{"name":383,"class":50},"Charles University, Czech Republic",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":18,"minAge":88,"maxAge":267,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":396,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100491710","luchtbrug-junior-the-next-step-100491710","NCT05682664","Luchtbrug Junior: the Next Step","Luchtbrug Junior: Online Monitoring for Young Children With Preschool Wheeze","Inclusion criteria\n\n* Children aged 2 to 6 years with a doctor's diagnosis of preschool wheeze\n* Children have an indication for regular follow-up of at least one year by a paediatrician because of respiratory symptoms;\n* Children are treated with inhaler medication, including inhaled corticosteroids;\n* A history of three episodes of wheezing managed by a healthcare professional of which at least one was observed by a paediatrician in the last 12 months prior to the study, or:\n* At least one hospital admissions due to pulmonary symptoms before inclusion.\n* Informed consent of parents\u002Fcaregivers\n\nExclusion criteria\n\n* Underlying chronic cardiopulmonary or neuromuscular condition, or known recurrent aspirations;\n* Underlying syndromes associated with pulmonary comorbidities;\n* Prematurity \\\u003C36 weeks after gestation;\n* Inability of parents\u002Fcaregivers\u002Fcaretakers to understand and\u002For read Dutch;\n* No access to a smartphone and\u002For internet.",{"count":392,"type":22},270,[25],"Rationale:\n\nThe introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, \"Luchtbrug\", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age).\n\nObjective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50%\n\nStudy design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care.\n\nFollow-up: 12 months.\n\nStudy population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea).\n\nIntervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135)\n\nMain study parameters\u002Fendpoints:\n\nPrimary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months).\n\nSecondary objectives:\n\nHealthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents\u002Fcaregivers.\n\nUsual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire.\n\nOnline care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents\u002Fcaregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents\u002Fcaregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.",[38,215,30],"NOT_YET_RECRUITING","2024-06-07",{"date":399,"type":43},"2024-06-10",{"date":401,"type":22},"2024-08-01",{"date":403,"type":22},"2027-02-01",{"name":405,"class":50},"Radboud University Medical Center",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":18,"minAge":413,"maxAge":19,"enrollmentInfo":414,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":51},"100534348","longitudinal-preschool-wheeze-biomarker-study-100534348","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.","1 Year",{"count":415,"type":22},150,"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)",[30],[419,420,154,421,422],"Preschool wheeze","Preschool asthma","Infection","Steroids","2024-04-26",{"date":425,"type":43},"2024-04-29",{"date":427,"type":43},"2024-02-01",{"date":429,"type":22},"2026-08-31",{"name":431,"class":50},"Imperial College London",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":17,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":438,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":439,"conditions":440,"keywords":445,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":51},"100536929","the-gut-lung-axis-and-respiratory-illness-in-children-100536929","NCT06271213","The Gut-Lung Axis and Respiratory Illness in Children","Inclusion Criteria:\n\n* Any infant\u002Fchild\u002Fyoung person admitted to the RHC, Glasgow for an elective bronchoscopy or GI endoscopy.\n* Any infant\u002Fchild attending for an emergency\u002Felective orthopaedic operation without active respiratory or gastrointestinal conditions or receiving treatment for either condition. (Age range birth to 16 years for all groups recruited).\n* Any child attending respiratory department at RHC who can induce sputum and is having a blood sample taken, with latter part of standard of care.\n* Any infant\u002Fchild\u002Fyoung person admitted to RHC for a clinical care appointment with Asthma\u002Fwheeze before commencement of biologics therapy (treatment group).\n* Any child admitted to RHC with asthma\u002Fwheeze not indicated for biologic therapy (asthma control group).\n\nExclusion Criteria:\n\n* Use of antibiotics by the day of admission or have used antibiotics in the previous month (unless prophylactic antibiotics \\> 1 month use).\n* Any person 17 years old and above.\n* Any child known to be infected with, or at high risk of having had exposure to HIV, hepatitis B or hepatitis C viruses\n* . Any child and\u002For parent\u002Fguardian who cannot understand the English language where consent would be unethical.\n* Any child with Asthma currently receiving Biologics therapy (unless recruited via bronchoscopy route).",{"count":415,"type":22},"The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the \"gut-lung axis\" in health and disease.\n\nPart A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:\n\n* What does a healthy gut-lung axis look like?\n* Do children with respiratory issues show an altered gut microbiome?\n* Do children with GI issues show an altered lung microbiome?\n\nPart B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).\n\nParticipants will provide:\n\n* airway samples (to investigate the lung microbiome)\n* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care\n* stool samples (to assess gut microbiome)\n* dietary information (food diary and\u002For food frequency questionnaire) to assess relationships between diet and the gut-lung axis.",[441,442,29,30,443,444],"Respiration Disorders","Respiratory Disease","Gastro-Intestinal Disorder","Healthy",[446,447,448,36],"Gut-Lung Axis","Microbiome","Multi-omics","2024-02-14",{"date":451,"type":43},"2024-02-21",{"date":453,"type":43},"2024-02-04",{"date":455,"type":22},"2028-05-01",{"name":457,"class":50},"NHS Greater Glasgow and Clyde"]