[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-asthma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637491","bilevel-positive-airway-pressure-bpap-for-severe-asthma-100637491",false,"NCT07582211","Bilevel Positive Airway Pressure (BPAP) for Severe Asthma","Bilevel Positive Airway Pressure (BPAP) for Severe Asthma Exacerbations: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.\n2. Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above).\n\nExclusion Criteria:\n\n1. Prior participation in the study.\n2. Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization.\n3. Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.\n4. If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.\n\n   Note: Blood gas values are not required for eligibility confirmation.\n5. Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician.\n6. Presence of a tracheostomy or a baseline requirement for noninvasive ventilation.\n7. Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis).\n8. Absolute or relative contraindication to BPAP, defined as any of the following:\n\n   1. Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull).\n   2. Uncontrollable vomiting (i.e., \\> 3 episodes within approximately 1 hour prior to being approached for consent).\n   3. Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \\\u003C 70 + \\[2 x age in years\\]).\n   4. Glasgow Coma Score of 8 or less.\n   5. Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema).\n9. Weight \\\u003C 20 kg.\n10. Presence of an intra-abdominal mass compressing the stomach (e.g., due to tumor or large volume ascites) through EMR or medical history.\n11. Known or suspected pregnancy by history or if pregnancy test completed by clinical team.\n12. Any medical condition that, in the opinion of a site investigator, could 1) lead to difficulty complying with protocol procedures, 2) interfere with the safe completion of the study, or 3) affect the validity of the endpoint assessments.\n13. PRAM score less than 7 or greater than 10 based on concurrent clinical assessment by a healthcare provider after completion of standard first-line therapies, which is defined as receiving all of the following prior to ED arrival or during the ED encounter for this acute asthma exacerbation:\n\n    1. Albuterol with or without ipratropium bromide, either at least 3 albuterol doses via inhalation method (e.g., metered-dose inhaler (MDI) or nebulized) or at least one hour of continuous albuterol (i.e., continuous nebulized albuterol or three consecutive intermittent nebulized albuterol treatments as bridging therapy).\n    2. Corticosteroids (e.g., Prednisolone, Prednisone, Dexamethasone\u002FDecadron, or Methylprednisolone) via enteral, intravenous, or intramuscular methods.\n\n    Note: Oxygen is not a required first-line therapy.\n14. Do not require continuous albuterol or a second round of albuterol treatments (e.g., three back-to-back treatments or one hour of burst albuterol treatment) following completion of standard first-line therapies.","ALL","5 Years","17 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to assess the feasibility of early initiation of bilevel positive airway pressure (BPAP) in the emergency department (ED) for children with severe asthma exacerbations. It will also collect preliminary data on the safety and potential effectiveness of this approach.\n\nThe main questions it aims to answer are:\n\n1. Can eligible patients be successfully enrolled and complete study procedures across multiple sites?\n2. What safety events occur with early BPAP use in this population?\n3. How do clinical outcomes (such as symptom improvement and need for intensive care) compare between early BPAP and standard care?\n\nResearchers will compare early initiation of BPAP plus standard asthma therapy to standard asthma therapy alone to determine whether early BPAP is a feasible and potentially beneficial treatment strategy.\n\nParticipants will 1) receive standard asthma therapy with or without early BPAP in the ED, 2) be monitored closely during the ED visit and hospitalization, and 3) have clinical data collected from routine care, including asthma severity scores, treatments, and outcomes.\n\nThe study will enroll approximately 36 participants (about 12 per site) across three sites over one year to inform a future multicenter randomized controlled trial.",[27,28,29,30],"Pediatric Asthma","Acute Asthma","BiPAP","Non-invasive Positive Pressure Ventilation","NOT_YET_RECRUITING","2026-05-13",{"date":34,"type":35},"2026-05-15","ACTUAL",{"date":37,"type":21},"2026-06",{"date":39,"type":21},"2027-08",{"name":41,"class":42},"Columbia University","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100623905","phase-4-dosing-of-steroids-for-acute-asthma-given-in-the-emergency-department---a-pilot-randomised-feasibility-trial-of-dexamethasone-in-children-100623905","NCT07402707","Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children","DOSAGE","Inclusion Criteria:\n\n* Children aged 4-15 years (inclusive) presenting to the ED with an asthma exacerbation, where oral steroids are recommended by Trust\u002FNational guidelines.\n* Children whose parents\u002Fcarers do not speak English will also be eligible provided they speak one of the common languages where an interpreter and Information Sheets are available (Slovakian, Arabic and Urdu).\n\nExclusion Criteria:\n\n* Children who have been treated with oral or IV steroids in the last 2 weeks.\n* Hypersensitivity to the study drug.\n* Children who have concomitant stridor.\n* First episode of wheezing (not previously diagnosed as asthma).\n* Children with known difficult asthma who receive longer courses of steroids as standard.\n* Life threatening episode of asthma.\n* Children with other conditions that require them to have steroids when unwell.\n* Children who are involved in current research or have recently been involved in research prior to recruitment","4 Years","15 Years",{"count":54,"type":21},104,[56],"PHASE4","Steroids given by mouth are an important first line treatment for children presenting with asthma attacks. Dexamethasone is the steroid used in some emergency departments (EDs) because of the need for a single dose and as it is well tolerated. The dose of dexamethasone in treating asthma attacks is not clearly established. This study compares two different doses of dexamethasone in children presenting with an asthma attack. Investigators will compare the effect of two different doses in reducing the need for a repeat prescription of steroids for an asthma attack in the 2 weeks after the first treatment. The investigators will also look at how often children attend the ED or their GP after being given treatment as well as the acceptability to parents and children. Although this study may provide an answer to the question of whether the different doses have the same effect, the investigators believe that a larger study will be needed to provide robust generalisable evidence, as well as to ensure that the outcomes are truly what matters to parents, children and healthcare professionals. This study will provide valuable information to enable a larger study to be undertaken.",[28,59],"Dexamethasone",[59],"RECRUITING","2026-04-20",{"date":64,"type":35},"2026-04-23",{"date":66,"type":35},"2026-02-23",{"date":68,"type":21},"2026-08-31",{"name":70,"class":42},"Sheffield Children's NHS Foundation Trust",1]