[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639221":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":20,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants cared for under bCPAP team-based care strategy","EXPERIMENTAL","This single arm includes pediatric participants and their caregivers, nurses, and physicians enrolled during pre-implementation and post-implementation periods based on timing of hospital presentation. A team-based, unit-level bCPAP care implementation strategy is introduced between periods and may include provider education, local champion engagement, training activities, and supportive supervision, with potential refinement over time. Outcomes are compared across pre- and post-implementation cohorts, which consist of different participants.",[13],"Behavioral: bCPAP team-based care strategy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","bCPAP team-based care strategy","This intervention consists of an adaptable, team-based implementation strategy to support delivery of bubble continuous positive airway pressure (bCPAP) in routine clinical care. The strategy is implemented at the unit level and may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. These components are designed to improve provider knowledge, skills, teamwork, communication, and caregiver understanding related to bCPAP use. The strategy may be refined over time based on local context and implementation needs. The intervention does not assign bCPAP directly but seeks to enhance the uptake, fidelity, and quality of its use within standard clinical practice. bCPAP is already available and used in participating units; this intervention does not involve introduction of a new device but rather focuses on improving the delivery and quality of existing care.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Nadir Ijaz, MD, MHS","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","(203) 785-4148","nadir.ijaz@yale.edu",[31,46],{"facility":32,"status":20,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Abbasi Shaheed Hospital","Karachi","Pakistan","PK",{"type":37,"coordinates":38},"Point",[39,40],67.0104,24.8608,{"lat":40,"lon":39},[43],{"name":44,"role":27,"phone":20,"phoneExt":20,"email":45},"Ibrahim Shakoor, MBBS","ishakoor@yahoo.com",{"facility":47,"status":20,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"Aga Khan University Hospital",{"type":37,"coordinates":49},[39,40],{"lat":40,"lon":39},[52],{"name":53,"role":27,"phone":54,"phoneExt":20,"email":55},"Qalab Abbas, MBBS","+922134864796","qalab.abbas@aku.edu",{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[59],{"name":60,"class":61},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100639221","bubble-cpap-team-based-care-strategy-feasibility-trial-100639221",false,"NCT07620054","Bubble CPAP Team-Based Care Strategy Feasibility Trial","Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan","Inclusion Criteria:\n\nPediatric participants:\n\n* Provision of signed and dated informed consent form by legal guardian (as determined by local policies and laws)\n* Stated willingness (by guardian) to comply with all study procedures and availability for the duration of the study\n* Presentation to the Emergency Department with cough or difficulty breathing (as documented in triage notes)\n* Meeting the World Health Organization definition for severe pneumonia: Exhibiting severe respiratory distress (clinical respiratory score of at least 8) OR Exhibiting hypoxemia (SpO2\\\u003C90%) OR Exhibiting a general danger sign (Vomiting everything (as reported by child's caregiver), Inability to feed (as reported by child's caregiver), Seizure\u002Fconvulsion (as documented in medical chart or reported by child's caregiver), Reduced level of consciousness (as assessed at screening)\n* In addition, exhibiting either:\n* Severe respiratory distress (clinical respiratory score of at least 8)\n* Hypoxemia (SpO2\\\u003C90%)\n\nPhysicians and nurses:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, over 18 years of age\n* Directly cared for any child receiving bCPAP therapy during the post-implementation period of the study\n\nCaregivers:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, any age\n* Primary caregiver at bedside of a child enrolled in the post-implementation period of our study.\n\nExclusion Criteria:\n\nPediatric participants:\n\n* Known congenital heart disease\n* Asthma\n* Upper airway obstruction\n* Tracheostomy\n\nPhysicians and nurses:\n\n* Temporarily rotating through the department, ward, or unit\n\nCaregivers:\n\n* Does not speak Urdu or English fluently","ALL","1 Month","59 Months",{"count":73,"type":74},95,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this pre\u002Fpost, effectiveness-implementation feasibility trial is to learn if a larger, multisite trial of a bubble continuous positive airway pressure (bCPAP) team-based care strategy is feasible in children with severe pneumonia. The main questions it aims to answer are:\n\nIs a future, larger, multisite trial of a bCPAP team-based care strategy feasible? Is the bCPAP team-based care strategy feasible and acceptable to clinicians and caregivers?",[80],"Pneumonia in Children",[82,83,84],"Bubble continuous positive airway pressure","Pneumonia","CPAP","NOT_YET_RECRUITING","2026-05-20",{"date":88,"type":89},"2026-06-02","ACTUAL",{"date":91,"type":74},"2028-04",{"date":93,"type":74},"2029-03",{"name":5,"class":6},2]