Efficacy and safety of targeting lower arterial oxygen saturations to reduce oxygen toxicity and oxidative stress in very preterm infants: The Canadian oxygen trial (COT)

Each year, Canadian hospitals care for well over one thousand babies who are born more than 12 weeks early. Between 40 and 50% of these extremely preterm infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. Many extremely preterm babies need extra oxygen to breathe. It is known that the amount of oxygen should not be too high because high levels are toxic to the eye, lung and brain. It is also known that blood oxygen levels should not drop too low, because the body requires adequate amounts of oxygen to function properly. However, the desirable target range for blood oxygen levels in very preterm babies remains poorly defined. A multi-centre randomized clinical trial is proposed in which 1200 tiny infants will be studied to help resolve this uncertainty in the care of extremely preterm infants. We will test if slightly less oxygen exposure reduces oxygen toxicity and improves survival without increasing disability in these vulnerable children.