Children’s Oxygen Administration Strategies Trial (COAST):  A randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia

File Description SizeFormat 
COAST protocolV2_wellcomeOpen.pdfPublished version2.58 MBAdobe PDFDownload
Title: Children’s Oxygen Administration Strategies Trial (COAST):  A randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia
Author(s): Maitland, K
Kiguli, S
Opoka, RO
Olupot-Olupot, P
Engoru, C
Njuguna, P
Bandika, V
Mpoya, A
Bush, A
Williams, TN
Grieve, R
Sadique, Z
Harrison, D
Rowan, K
Item Type: Journal Article
Abstract: Background: In Africa, the clinical syndrome of pneumonia remains the leading cause of morbidity and mortality in children in the post-neonatal period. This represents a significant burden on in-patient services. The targeted use of oxygen and simple, non-invasive methods of respiratory support may be a highly cost-effective means of improving outcome, but the optimal oxygen saturation threshold that results in benefit and the best strategy for delivery are yet to be tested in adequately powered randomised controlled trials. There is, however, an accumulating literature about the harms of oxygen therapy across a range of acute and emergency situations that have stimulated a number of trials investigating permissive hypoxia. Methods: In 4200 African children, aged 2 months to 12 years, presenting to 5 hospitals in East Africa with respiratory distress and hypoxia (oxygen saturation < 92%), the COAST trial will simultaneously evaluate two related interventions (targeted use of oxygen with respect to the optimal oxygen saturation threshold for treatment and mode of delivery) to reduce shorter-term mortality at 48-hours (primary endpoint), and longer-term morbidity and mortality to 28 days in a fractional factorial design, that compares: Liberal oxygenation (recommended care) compared with a strategy that permits hypoxia to SpO2 > or = 80% (permissive hypoxia); and High flow using AIrVO2TM compared with low flow delivery (routine care). Discussion: The overarching objective is to address the key research gaps in the therapeutic use of oxygen in resource-limited setting in order to provide a better evidence base for future management guidelines. The trial has been designed to address the poor outcomes of children in sub-Saharan Africa, which are associated with high rates of in-hospital mortality, 9-10% (for those with oxygen saturations of 80-92%) and 26-30% case fatality for those with oxygen saturations <80%.
Publication Date: 11-Oct-2017
Date of Acceptance: 11-Oct-2017
URI: http://hdl.handle.net/10044/1/54643
DOI: https://dx.doi.org/10.12688/wellcomeopenres.12747.1
ISSN: 2398-502X
Publisher: F1000Research
Start Page: 100
End Page: 100
Journal / Book Title: Wellcome Open Research
Volume: 2
Copyright Statement: Copyright: © 2017 Maitland K et al. This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: Medical Research Council (MRC)
Wellcome Trust
Funder's Grant Number: MR/L004364/1
C163
Publication Status: Published
Article Number: 100
Appears in Collections:National Heart and Lung Institute
Department of Medicine
Faculty of Medicine



Items in Spiral are protected by copyright, with all rights reserved, unless otherwise indicated.

Creative Commons