Pneumonia in ChildrenNCT07620054
Bubble CPAP Team-Based Care Strategy Feasibility Trial
A study testing bCPAP team-based care strategy in people with Pneumonia in Children, run by Yale University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Pneumonia in Children
- What is being tested?
- bCPAP team-based care strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesPakistan
- Study dates
- Apr 2028to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 18Show fewer
- 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.
Who cannot join
- Pediatric participants:
- Known congenital heart disease
- Asthma
- Upper airway obstruction
- Tracheostomy
- Physicians and nurses:
Show all 9Show fewer
- Temporarily rotating through the department, ward, or unit
- Caregivers:
- Does not speak Urdu or English fluently
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Abbasi Shaheed Hospital
Karachi
Ibrahim Shakoor, MBBS, ishakoor@yahoo.com
Aga Khan University Hospital
Karachi
Qalab Abbas, MBBS, +922134864796, qalab.abbas@aku.edu
About this study
Official title: Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan
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?
Read the detailed description
This study is a single-group, pre-post implementation study designed to evaluate the feasibility and preliminary effectiveness of a team-based care strategy to improve delivery of bubble continuous positive airway pressure (bCPAP) among children presenting with severe pneumonia to participating hospitals.
The study uses a repeated cross-sectional design in which distinct cohorts of participants are enrolled during a 4-month pre-implementation period and a 4-month post-implementation period based on timing of emergency department presentation. A unit-level implementation strategy is introduced between these periods, and outcomes are compared across time rather than between concurrently assigned groups.
The intervention consists of an adaptable, team-based care implementation strategy to support delivery of bCPAP in routine clinical care. Components may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. The strategy may be refined over time based on local context and implementation needs. bCPAP is already available and used in participating units; this study does not involve introduction of a new device but instead focuses on improving the uptake, fidelity, and quality of its use within standard care.
The study population includes pediatric participants meeting criteria for severe pneumonia, as well as caregivers and clinicians who contribute survey and qualitative interview data related to implementation outcomes. Quantitative and qualitative data are collected to evaluate feasibility, acceptability, implementation fidelity, and clinical outcomes, including follow-up after presentation.
The primary objective is to assess feasibility of progression to a larger trial using predefined criteria. Secondary objectives include evaluating feasibility and acceptability of the implementation strategy and characterizing implementation processes in the post-implementation period.
Participants will:
- Be enrolled during either the pre-implementation or post-implementation period based on timing of hospital admission
- Have relevant clinical information obtained through medical record review
- Undergo a study-specific physical examination, as applicable
- Have their caregivers complete surveys assessing experiences, perceptions of care, and/or clinical outcomes
- Have treating clinicians complete surveys assessing implementation outcomes such as feasibility, acceptability, and usability
- Receive clinical care that may include bubble continuous positive airway pressure (bCPAP) delivered as part of routine practice
- Be cared for in units implementing an adaptable, team-based bCPAP care strategy, which may include provider education, local champion engagement, training activities, and supportive supervision, and may be refined over time based on implementation needs
- Be invited (subset of caregivers and clinicians) to participate in qualitative interviews to assess feasibility, acceptability, and experiences with the care strategy
- Be followed for 14 days after initial emergency department presentation to assess clinical outcomes, including mortality (via medical record review and/or caregiver contact, as applicable)
- Contribute data that will be compared across pre-implementation and post-implementation periods involving different participant cohorts
- Conditions
- Pneumonia in Children
- Being tested
- bCPAP team-based care strategy
- Keywords
- Bubble continuous positive airway pressure, Pneumonia, CPAP
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bCPAP team-based care strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: bCPAP team-based care strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Larger Trial
Feasibility of a larger trial of the bCPAP team-based care strategy, as assessed using predefined trial progression criteria, including recruitment and consent rates, completeness and quality of effectiveness outcomes data, and completeness and quality of implementation outcomes data, with evaluation against prespecified benchmarks defined in the study protocol. This is a composite measure defined as: if certain criteria are met, the study will proceed to a larger trial.
Measured: From enrollment through completion of 14-day follow-up
Secondary outcomes (4)
Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers
Assessed using qualitative interviews with caregivers, with thematic analysis of perceived feasibility, including barriers and facilitators to participation in bCPAP care processes.
Measured: Within 14 days after emergency department presentation during the post-implementation period
Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians
Assessed by tracking implementation activities, including frequency of clinician champion meetings, frequency of implementation data dissemination, and clinician attendance at bCPAP training sessions.
Measured: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Caregiver Engagement With bCPAP Educational Components
Assessed as the proportion of caregivers who view a bCPAP educational video during the clinical encounter.
Measured: Within 24 hours of bCPAP therapy initiation in the post-implementation period
Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy
Assessed as a composite evaluation of implementation outcomes, including caregiver-reported feasibility and acceptability (qualitative interviews), implementation fidelity among clinicians, and caregiver engagement with educational components. These domains will be considered together to characterize the overall feasibility and acceptability of the bCPAP team-based care strategy in routine clinical practice using a predefined framework to integrate findings across domains.
Measured: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startApr 2028 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia in ChildrenStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, pre-post implementation study in which different cohorts of participants are enrolled before and after rollout of a unit-level intervention. The intervention is applied at the hospital/unit level rather than assigned to individual participants, and outcomes are compared across time periods.
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nadir Ijaz, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620054
- Sponsor's protocol ID
- 2000042882
- Other IDs
- 1K23HL181402-01A1
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in publications will be shared, after de-identification, in accordance with applicable ethical, legal, and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Bubble Continuous Positive Airway Pressure Team-Based Care Strategy in Pakistan
- ClinicalTrials.gov ID
- NCT07620054
- Acronym / sponsor ID
- 2000042882
- Conditions
- Pneumonia in Children
- Keywords
- Bubble continuous positive airway pressure, Pneumonia, CPAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2028 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This study is a single-group, pre-post implementation study designed to evaluate the feasibility and preliminary effectiveness of a team-based care strategy to improve delivery of bubble continuous positive airway pressure (bCPAP) among children presenting with severe pneumonia to participating hospitals.
The study uses a repeated cross-sectional design in which distinct cohorts of participants are enrolled during a 4-month pre-implementation period and a 4-month post-implementation period based on timing of emergency department presentation. A unit-level implementation strategy is introduced between these periods, and outcomes are compared across time rather than between concurrently assigned groups.
The intervention consists of an adaptable, team-based care implementation strategy to support delivery of bCPAP in routine clinical care. Components may include provider education, preparation of local champions, training of clinical staff, caregiver education and engagement, and ongoing supportive supervision. The strategy may be refined over time based on local context and implementation needs. bCPAP is already available and used in participating units; this study does not involve introduction of a new device but instead focuses on improving the uptake, fidelity, and quality of its use within standard care.
The study population includes pediatric participants meeting criteria for severe pneumonia, as well as caregivers and clinicians who contribute survey and qualitative interview data related to implementation outcomes. Quantitative and qualitative data are collected to evaluate feasibility, acceptability, implementation fidelity, and clinical outcomes, including follow-up after presentation.
The primary objective is to assess feasibility of progression to a larger trial using predefined criteria. Secondary objectives include evaluating feasibility and acceptability of the implementation strategy and characterizing implementation processes in the post-implementation period.
Participants will:
- Be enrolled during either the pre-implementation or post-implementation period based on timing of hospital admission
- Have relevant clinical information obtained through medical record review
- Undergo a study-specific physical examination, as applicable
- Have their caregivers complete surveys assessing experiences, perceptions of care, and/or clinical outcomes
- Have treating clinicians complete surveys assessing implementation outcomes such as feasibility, acceptability, and usability
- Receive clinical care that may include bubble continuous positive airway pressure (bCPAP) delivered as part of routine practice
- Be cared for in units implementing an adaptable, team-based bCPAP care strategy, which may include provider education, local champion engagement, training activities, and supportive supervision, and may be refined over time based on implementation needs
- Be invited (subset of caregivers and clinicians) to participate in qualitative interviews to assess feasibility, acceptability, and experiences with the care strategy
- Be followed for 14 days after initial emergency department presentation to assess clinical outcomes, including mortality (via medical record review and/or caregiver contact, as applicable)
- Contribute data that will be compared across pre-implementation and post-implementation periods involving different participant cohorts
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, pre-post implementation study in which different cohorts of participants are enrolled before and after rollout of a unit-level intervention. The intervention is applied at the hospital/unit level rather than assigned to individual participants, and outcomes are compared across time periods.
| Arm | Type | Receives |
|---|---|---|
| Participants cared for under bCPAP team-based care strategy | Experimental | Behavioral: bCPAP team-based care strategyThis 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. |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (9 listed)
- Known congenital heart disease
- Asthma
- Upper airway obstruction
- Tracheostomy
- Temporarily rotating through the department, ward, or unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bCPAP team-based care strategyThis 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. | Behavioural | Participants cared for under bCPAP team-based care strategy |
Primary outcome
Feasibility of a Larger Trial
Time frame: From enrollment through completion of 14-day follow-up
Feasibility of a larger trial of the bCPAP team-based care strategy, as assessed using predefined trial progression criteria, including recruitment and consent rates, completeness and quality of effectiveness outcomes data, and completeness and quality of implementation outcomes data, with evaluation against prespecified benchmarks defined in the study protocol. This is a composite measure defined as: if certain criteria are met, the study will proceed to a larger trial.
4 secondary outcomes
Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers
Time frame: Within 14 days after emergency department presentation during the post-implementation period
Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians
Time frame: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Caregiver Engagement With bCPAP Educational Components
Time frame: Within 24 hours of bCPAP therapy initiation in the post-implementation period
Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy
Time frame: Throughout the post-implementation period (4 months) during delivery of the implementation strategy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in publications will be shared, after de-identification, in accordance with applicable ethical, legal, and regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadir Ijaz, MD, MHS principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bCPAP team-based care strategy in people with Pneumonia in Children, run by Yale University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadir Ijaz, MD, MHS ((203) 785-4148, nadir.ijaz@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Larger Trial (time frame: From enrollment through completion of 14-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.