Bubble CPAP Team-Based Care Strategy Feasibility Trial
Starting soon · Not applicable
Conditions studied: Pneumonia in Children
In brief
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?
Key facts
- Study ID
- NCT07620054
- Run by
- Yale University
- People needed
- 95
- Starts
- 2028-04-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 study
- Male or female, any age
- Primary caregiver at bedside of a child enrolled in the post-implementation period of our study.
You may not qualify if…
- Pediatric participants:
- Known congenital heart disease
- Asthma
- Upper airway obstruction
- Tracheostomy
- Physicians and nurses:
- Temporarily rotating through the department, ward, or unit
- Caregivers:
- Does not speak Urdu or English fluently
Where it is running
- Abbasi Shaheed Hospital — Karachi, Pakistan
- Aga Khan University Hospital — Karachi, Pakistan
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.