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Effect of bubble-continuous positive airway pressure (CPAP) on outcome of severe childhood pneumonia and neonatal respiratory distress in children in Papua New Guinea and Solomon Islands

In the management of severe pneumonia in children and neonatal respiratory distress, does bubble-CPAP, when delivered by a modified oxygen concentrator, compared to standard flow oxygen therapy, result in lower risk of death or clinical failure

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001294842
Enrollment
2800
Registered
2012-12-13
Start date
2013-03-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Despite the availability of effective antibiotics for the common causes of bacterial pneumonia, and despite the availability of oxygen, in Papua New Guinea the death rate for pneumonia sick enough to require hospital admission is 5%, and the death rate for severe pneumonia is 11%. This is similar in many resource-limited developing countries. Supportive care, including oxygen, fluids and nutrition are vital to reducing pneumonia death rates. Oxygen supplies are often unreliable in developing countries, and we have shown that in PNG oxygen has been most reliably and most efficiently delivered using concentrators. However in PNG and Solomon Islands oxygen is the highest level of respiratory support that can be provided to seriously ill children, there is no intensive care services. Continuous positive airway pressure (CPAP) is often used for severe respiratory distress in developed countries, but CPAP has not been available in developing countries because of cost and complexity. We are trialling a form of CPAP that does not require external sources of oxygen, or external source of medical air, but delivers bubble-CPAP through a modified high-flow oxygen concentrator that can give an air-oxygen mixture. This technology is being trialled in 9 provincial hospitals in PNG and the Solomon Islands, where pneumonia is the number 1 cause of child deaths. The aim of the study is to evaluate whether bubble-CPAP will reduce death rates from pmeumonia, and reduce death rates for newborns with respiratory distress

Interventions

Bubble-continuous positive airway pressure (CPAP) using a modified oxygen concentrator, the level of CPAP being 4-8 cmH20, with a fraction of inspired oxygen between 25-60%, using flow rates of around 6 L/min for neonates and 10 L/min for older infants and children. CPAP will be administered continuously, until signs of severe respiratory distress and hypoxaemia resolve. Daily assessments of the degree of respiratory distress will guide when it is clinically safe to stop CPAP

Sponsors

School of Medicine & Health Sciences, University of Papua New Guinea
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 5 Years
Healthy volunteers
No

Inclusion criteria

Children admitted with pneumonia and hypoxaemia (SpO2<90%, or less than 86% in highlands) or neonates with respiratory distress and hypoxaemia.

Exclusion criteria

Congenital heart disease Previous enrollment Pneumothorax

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026