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

Kathryn Maitland, Imperial College London, UK.
Sarah Kiguli, Makerere College of Health Sciences, Uganda.
Robert Opoka, Aga Khan University
Peter Olupot -Olupot, Mbale Clinical Research Institute, Uganda.
Charles Engoru, Soroti Regional Referral Hospital, Uganda.
Patricia Njuguna, KEMRI-Wellcome Trust Research Programme, UK.
Victor Bandika, Coast Provincial General Hospital, Kenya.
Ayub Mpoya, KEMRI-Wellcome Trust Research Programme, UK.
Andrew Bush, Imperial College London, UK.
Thomas N. Williams, Imperial College London, UK.
Richard Grieve, London School of Hygiene & Tropical Medicine, UK.
Zia Sadique, London School of Hygiene & Tropical Medicine, UK.
John Fraser, University of Queensland
David Harrison, Intensive Care National Audit & Research Centre (ICNARC), UK.
Kathy Rowan, Intensive Care National Audit & Research Centre (ICNARC), UK.

This work was published before the author joined Aga Khan University.


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. In 4200 African children, aged 2 months to 12 years, presenting to 5

Methods: 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 > or = 80% (permissive hypoxia); and High flow using AIrVO compared with low flow delivery (routine care). The overarching objective is to address the key research gaps in

Discussion: 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%