Children's Oxygen Administration Strategies Trial (COAST): a randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia
What is this study about?
Pneumonia is swelling, or inflammation, of the tissue in the lungs and is usually caused by a bacterial infection. It is a life-threatening condition and is one of the leading causes of childhood death in sub-Saharan Africa. Alongside antibiotics, the World Health Organization recommends delivering oxygen to children who have severe pneumonia or hypoxia – when there is a low level of oxygen in the tissues. Although giving oxygen is a basic element of hospital care, this treatment is costly and supplies are inadequate and inconsistent in African hospitals. The aim of this study is to identify what would be the best oxygen delivery method in children admitted to African hospitals with hypoxia and signs of severe pneumonia.
Participants in the study will include children aged between 28 days and 12 years with a history of respiratory illness, hypoxia (lack of adequate oxygen supply) and signs of severe pneumonia (lung inflammation).
Treatment will follow one of two routes based on level of oxygen in the child’s blood, or how severe hypoxia they have:
- For children with less severe hypoxia (oxygen levels between 80% and 92%), they will be randomly allocated to either receive oxygen, either at a higher flow or lower flow (usual care), or not receive oxygen.
- For children with more severe hypoxia (oxygen levels less than 80%), they will be randomly allocated to receive oxygen either at a higher flow or lower flow (usual care).
Where is the study run from?
Five hospitals across Kenya and Uganda
When is it taking place?
December 2016 to November 2019
Who is funding the study?
Joint Global Health Trials scheme (UK Medical Research Council, UK Department for International Development and the Wellcome Trust)