Bubble CPAP Team-Based Care Strategy Feasibility Trial

NCT07620054 | Not Yet Recruiting

• 2 other identifiers: 20000428821K23HL181402-01A1
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief 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?

Conditions

Pneumonia in Children

Keywords

Bubble continuous positive airway pressure; Pneumonia; CPAP

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment through completion of 14-day follow-up

Secondary Outcomes (4)

• Feasibility of the bCPAP Team-Based Care Strategy Among Caregivers

  Within 14 days after emergency department presentation during the post-implementation period

• Implementation Fidelity to the bCPAP Team-Based Care Strategy Among Clinicians

  Throughout the post-implementation period (4 months) during delivery of the implementation strategy

• Caregiver Engagement With bCPAP Educational Components

  Within 24 hours of bCPAP therapy initiation in the post-implementation period

• Overall Feasibility and Acceptability of the bCPAP Team-Based Care Strategy

  Throughout the post-implementation period (4 months) during delivery of the implementation strategy

Study Arms (1)

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.

Behavioral: bCPAP team-based care strategy

Interventions

bCPAP team-based care strategy BEHAVIORAL

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.

Participants cared for under bCPAP team-based care strategy

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

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

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Abbasi Shaheed Hospital

Karachi, Pakistan

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nadir Ijaz, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadir Ijaz, MD, MHS

CONTACT

(203) 785-4148; nadir.ijaz@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): April 1, 2028
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available immediately at the time of publication of the results. Data will be available for at least 5 years.
• Access Criteria: Data will be shared via an open access repository.

Locations

PA (2)