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Optimizing Severe Pneumonia Management in Children Through Scale up of Bubble continuous positive airway pressure (bCPAP) technology in Low Resource Settings (OPT-bCPAP

Optimizing Severe Pneumonia Management in Children Through Scale up of Bubble continuous positive airway pressure (bCPAP) technology in Low Resource Settings (OPT-bCPAP: Type 1 Effectiveness-Implementation Hybrid Design. OPT-bCPAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605762714748
Enrollment
7224
Registered
2026-05-08
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory

Interventions

Improvised bubble CPAP

Sponsors

Armauer Hansen Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All children aged 1-59 months with WHO classified severe pneumonia, admitted to study hospitals, will be assessed for inclusion. In addition, they will need to have at least one of these criteria: (i) Children with SpO2 =70/min and head nodding synchronous with respiration or nasal flaring or tracheal tugging). (iv) Parent or Legal guardian or caregiver is present and able to provide consent

Exclusion criteria

Exclusion criteria: 1. Known congenital heart disease 2. LRTI with wheeze responsive to bronchodilators and SpO2 = 90% 3. Stridor 4. Tracheostomy 5. Pneumothorax 6. Cerebral malaria on admission 7. Requirement for mechanical ventilation for any specific reason as decided by the clinician.

Design outcomes

Primary

MeasureTime frame
Treatment failure is defined if any of the following criteria is met: ? Presence of severe hypoxaemia (SpO2 < 90%) after one hour of receiving oxygen (either low-flow or bCPAP) ? Presence or worsening of respiratory distress signs after 48 hours of oxygen therapy ? Death during hospitalization ? Development of an indication for mechanical ventilation, as determined by the clinician ? Referral to a higher-level facility, as determined by the clinician

Secondary

MeasureTime frame
Inpatient Mortality;Length of Hospital Stay;Escalation of care, which includes clinician indication for mechanical ventilation, or referral for higher care at any point during their admission

Countries

Ethiopia, Malawi, Nigeria

Contacts

Public ContactCynthia Baard

Project Manager

cynthia.baard@uct.ac.za+27721706436

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026