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Paediatric lung disease
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
  1. Andrew G Smith1,
  2. Michelle Eckerle2,
  3. Tisungane Mvalo3,
  4. Brian Weir4,
  5. Francis Martinson3,
  6. Alfred Chalira5,
  7. Norman Lufesi5,
  8. Innocent Mofolo3,
  9. Mina Hosseinipour6 and
  10. Eric D McCollum4,7
  1. 1 Paediatric Critical Care Medicine, University of Utah, Salt Lake City, Utah, USA
  2. 2 Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
  3. 3 UNC Malawi Project, Lilongwe, Malawi
  4. 4 Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  5. 5 Malawi Ministry of Heath, Lilongwe, Malawi
  6. 6 Division of Infectious Disease, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  7. 7 Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Dr Eric D McCollum; emccoll3{at}jhmi.edu

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.

  • Pneumonia
  • Paediatric Lung Disease

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjresp-2017-000195

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    Footnotes

    • Twitter @tinylungsglobal

    • Contributors EDM conceived the study and participated in the design of the study, implementation of the study, revising of the manuscript and approved the final manuscript. AGS, ME and TM participated in the design of the study, implementation of the study, revising of the manuscript and approved the final manuscript. FM, AC, NL, IM and MH participated in the design of the study, revising of the manuscript and approved the final manuscript. BW provided statistical expertise in clinical trial design and revising of the manuscript and approved the final manuscript.

    • Funding This research is supported in part by a grant from the Bill and Melinda Gates Foundation (OPP1123419) and a CIPHER grant from the International AIDS Society (141022), supported by founding sponsor ViiV Healthcare. The views expressed in this manuscript do not necessarily reflect the official policies of the International AIDS Society or ViiV Healthcare. The funders approved the protocol design and have oversight of ongoing study activities. Final analysis and publication of results will be at the sole digression of the study investigators. Analytic support for this trial is provided by the Center for Child and Community Health Biostatistics, Epidemiology and Data Management Core, Johns Hopkins School of Medicine.

    • Competing interests None declared.

    • Ethics approval Johns Hopkins University, University of Cincinnati and the Malawi Ministry of Health Institutional Review Boards.

    • Provenance and peer review Not commissioned; externally peer reviewed.