Can a team approach to bubble CPAP help kids with pneumonia? a feasibility trial begins
NCT ID NCT07620054
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a team-based care strategy for bubble continuous positive airway pressure (bCPAP) is feasible for children with severe pneumonia in Pakistan. Researchers will enroll 95 children and their caregivers to see if a larger trial is possible. The focus is on whether the strategy is practical and acceptable to clinicians and families, not on proving it improves health outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bubble continuous positive airway pressure (bCPAP) team-based care strategy
- What this could lead to
- If successful, this could show that a team-based approach to delivering bCPAP is practical in hospitals, paving the way for a larger trial to improve breathing support for children with severe pneumonia.
- What could go wrong
- This is a small feasibility trial with only 95 participants, not designed to prove the strategy works. It may not show clear benefits or be accepted by all clinicians and caregivers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 95 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2028
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 59 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 study * Male or female, any age * Primary caregiver at bedside of a child enrolled in the post-implementation period of our study. Exclusion Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abbasi Shaheed Hospital
Karachi, Pakistan
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Aga Khan University Hospital
Karachi, Pakistan
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