Bubble CPAP Team-Based Care Strategy Feasibility Trial
Pakistan95 participantsStarted 2028-04
Plain-language summary
The goal of this pre/post, 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:
Is 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?
Who can participate
Age range
1 Month – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Pediatric participants:
* Provision of signed and dated informed consent form by legal guardian (as determined by local policies and laws)
* Stated willingness (by guardian) to comply with all study procedures and availability for the duration of the study
* Presentation to the Emergency Department with cough or difficulty breathing (as documented in triage notes)
* Meeting the World Health Organization definition for severe pneumonia: Exhibiting severe respiratory distress (clinical respiratory score of at least 8) OR Exhibiting hypoxemia (SpO2\<90%) OR Exhibiting a general danger sign (Vomiting everything (as reported by child's caregiver), Inability to feed (as reported by child's caregiver), Seizure/convulsion (as documented in medical chart or reported by child's caregiver), Reduced level of consciousness (as assessed at screening)
* In addition, exhibiting either:
* Severe respiratory distress (clinical respiratory score of at least 8)
* Hypoxemia (SpO2\<90%)
Physicians and nurses:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, over 18 years of age
* Directly cared for any child receiving bCPAP therapy during the post-implementation period of the study
Caregivers:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the stud…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of a Larger Trial
Timeframe: From enrollment through completion of 14-day follow-up