Bubble CPAP Team-Based Care Strategy Feasibility Trial
ConditionPneumonia in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-59
SponsorYale University
About this trial
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?
Eligibility criteria
Qualifiers
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)
Disqualifiers
Known congenital heart disease
Asthma
Upper airway obstruction
Tracheostomy
Trial design
Treatments tested in this trial
- bCPAP team-based care strategy
Treatment groups
95 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov