Send to

Choose Destination
Wellcome Open Res. 2017 Oct 11;2:100. doi: 10.12688/wellcomeopenres.12747.1. eCollection 2017.

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 information

Department of Paediatrics, Faculty of Medicine, KEMRI-Wellcome Trust Research Programme, London, W2 1PG, UK.
Department of Paediatrics, Mulago Hospital, Makerere College of Health Sciences, Kampala, Uganda.
Department of Paediatrics, Mbale Regional Referral Hospital, Mbale, Uganda.
Mbale Clinical Research Institute, Mbale, Uganda.
Kilifi Clinical Trials Facility, KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Department of Paediatrics, Coast Provincial General Hospital, Mombasa, Kenya.
Department of Paediatric Respirology, National Heart and Lung Institute, Royal Brompton & Harefield NHS Foundation Trust, Imperial College, London, SW3 6NP, UK.
Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, WC1H 9SH, UK.
Intensive Care National Audit & Research Centre (ICNARC), London, WC1V 6AZ, UK.


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 SpO 2 > or = 80% (permissive hypoxia); andHigh flow using AIrVO 2TM 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%. Clinical trial registration: ISRCTN15622505 Trial status: Recruiting.


Africa; AirVO2 High flow oxygen; Children; Emergency Care Hypoxia Pneumonia Randomised controlled trial; Permissive hypoxia

Supplemental Content

Full text links

Icon for F1000 Research Ltd Icon for PubMed Central
Loading ...
Support Center