Every year, thousands of African children hospitalised with pneumonia and low blood oxygen die because doctors lack clear evidence on when to give oxygen and how to deliver it. The COAST trial will randomise 4,200 children in Uganda and Niger to test two linked questions: whether oxygen improves survival for children with moderate hypoxia (oxygen saturations between 80% and 92%), and whether high-flow oxygen—which keeps airways open—saves more lives than standard low-flow delivery. Currently, 9–10% of children with moderate hypoxia die in hospital, rising to 26–30% for severe cases. Many hospitals in low-income countries ration oxygen because supplies are erratic and expensive, forcing clinicians to make decisions without data. If the trial shows that targeting a specific oxygen saturation threshold and using high-flow oxygen reduces 48-hour mortality, it will give policymakers the evidence to allocate scarce resources effectively, refine treatment guidelines, and pressure health systems to expand oxygen access. This is not fundamental science—it is a pragmatic trial designed to change clinical practice directly, potentially saving thousands of lives each year across sub-Saharan Africa.
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The Children's Oxygen Administration Strategies Trial (COAST) is a multicentre randomised controlled trial aimed at identifying which children admitted to hospital with suspected pneumonia with a low level of oxygen in their blood (called hypoxia) would benefit from oxygen and whether oxygen is best delivered by low flow (routine care) or by high flow. Although oxygen is a basic element of hospital care, there are no relevant studies to guide which level of oxygen saturation should be target for its use and what is the best method of how to administer it (low flow or high flow) to improve outcome. In practise many children in low-income countries do not receive oxygen, despite being recommended, owing to the lack of its availability due to the high cost, or supplies that are unpredictable (erratic delivery of cylinders or electricity to power oxygen concentrators) resulting in mismatch between supply and demand. We will enrol 4200 African children, aged 2 months to 12 years, at admission to hospital with respiratory distress complicated by low oxygen levels (defined as a blood oxygen saturation, SaO2 level below 92%) over 30 months in 4 hospital in 2 countries (Uganda and Niger) and follow the children up over a period of 28 days. COAST trial will evaluate two related components of management. 1/ Who to give oxygen too? Children who are admitted to hospital in Africa with hypoxia have a poorer in-hospital outcome than children with normal oxygen levels. For children with hypoxia (oxygen saturations between 80% and 92%) between 9-10% will die in hospital, similarly 26-30% will die if they have severe hypoxia (oxygen saturations <80%). COAST will examine whether or not oxygen improves outcome in hypoxia and the best threshold for giving oxygen in children without severe hypoxia (oxygen saturations 80% - 92%). Children with severe hypoxia (SaO2 <80%) will all receive oxygen as we less unsure about the benefits of oxygen in this group. For the children with SaO2 between 80 and 92% we are not certain which is the best level to provide oxygen and whether this will result in a better outcome - so half of the children will receive oxygen the other half will not receive oxygen. 2. How best to give oxygen? We will compare whether giving oxygen through a tube with two small prongs into the nose low flow (standard of care) to high flow in all children receiving oxygen. High flow oxygen provides extra pressure to the airways to prevent them from collapsing after every expiratory breath. High flow is safe and well tolerated in children and babies - as it helps reduce effort of breathing in critically sick children, which is substantial when lungs are congested with infection, that often leads to respiratory exhaustion and ultimately respiratory failure in the children who cannot access mechanical ventilation (the majority of hospitals in Africa). The major aim (or outcome) is to reduce shorter-term mortality at 48-hours (primary endpoint) and longer-term morbidity and mortality to 28 days. A trial demonstrating that oxygen is an important life saving treatment will provide important new evidence for which level of oxygen saturation to target oxygen therapy that is both clinically beneficial and cost-effective for health services. This would lead to substantial refinements to treatment recommendations and can be used to put pressure on health services for wider implementation - allowing policymakers to make decisions on how best to allocate scarce health resources.
Andrew Bush (Co-Investigator)Charles Engoru (Co-Investigator)David Harrison (Co-Investigator)Isabelle Defourney (Co-Investigator)Kathryn Maitland (Principal Investigator)Kathy Rowan (Co-Investigator)Nicole Anne Margaret Blackwell (Co-Investigator)Patricia Njuguna (Co-Investigator)Peter Olupot-Olupot (Co-Investigator)Sarah Kiguli (Co-Investigator)Thierry Allafort-Duverger (Co-Investigator)Thomas Williams (Co-Investigator)
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