CPAP IMPACT: a protocol for a randomised trial of bubble continuous positive airway pressure versus standard care for high-risk children with severe pneumonia using adaptive design methods

Andrew G Smith, Michelle Eckerle, Tisungane Mvalo, Brian Weir, Francis Martinson, Alfred Chalira, Norman Lufesi, Innocent Mofolo, Mina Hosseinipour, Eric D McCollum, Andrew G Smith, Michelle Eckerle, Tisungane Mvalo, Brian Weir, Francis Martinson, Alfred Chalira, Norman Lufesi, Innocent Mofolo, Mina Hosseinipour, Eric D McCollum

Abstract

Introduction: Pneumonia is a leading cause of mortality among children in low-resource settings. Mortality is greatest among children with high-risk conditions including HIV infection or exposure, severe malnutrition and/or severe hypoxaemia. WHO treatment recommendations include low-flow oxygen for children with severe pneumonia. Bubble continuous positive airway pressure (bCPAP) is a non-invasive support modality that provides positive end-expiratory pressure and oxygen. bCPAP is effective in the treatment of neonates in low-resource settings; its efficacy is unknown for high-risk children with severe pneumonia in low-resource settings.

Methods and analysis: CPAP IMPACT is a randomised clinical trial comparing bCPAP to low-flow oxygen in the treatment of severe pneumonia among high-risk children 1-59 months of age. High-risk children are stratified into two subgroups: (1) HIV infection or exposure and/or severe malnutrition; (2) severe hypoxaemia. The trial is being conducted in a Malawi district hospital and will enrol 900 participants. The primary outcome is in-hospital mortality rate of children treated with standard care as compared with bCPAP.

Ethics and dissemination: CPAP IMPACT has approval from the Institutional Review Boards of all investigators. An urgent need exists to determine whether bCPAP decreases mortality among high-risk children with severe pneumonia to inform resource utilisation in low-resource settings.

Trial registration number: NCT02484183; Pre-results.

Keywords: Paediatric Lung Disease; Pneumonia.

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Inclusion criteria.
Figure 2
Figure 2
bCPAP design. bCPAP, bubble continuous positive airway pressure.
Figure 3
Figure 3
Weaning protocol for bCPAP. bCPAP, bubble continuous positive airway pressure.
Figure 4
Figure 4
Weaning protocol for low-flow oxygen. LPM, liters per minute.
Figure 5
Figure 5
Projected enrolment.

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