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USA - Oxygen saturation in preterm infants: high or low?

Tildelt: kr 48 000





2005 - 2009

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Oxygen is one of the most common therapies for extremely low gestational age neonates (ELGANs) 24-28 weeks of gestational age. Yet, ELGANs are vulnerable to toxic effects. Oxygen related morbidities include severe retinopathy of prematurity (ROP), a leadi ng cause to blindness and visual disability, and chronic lung disease (CLD), a major cause of long term respiratory morbidity. Oxygen and oxidative stress may also contribute to neonatal brain injury. Each of these oxygen-related morbidities are asscoiat ed with poor growth and neurodevelopmetnal impairment. Unfortunately we do not know what is too high or too low oxygenation for ELGANs. A wide spectrum of opinion and practice exist in the oxygfenation of ELGANs. With no evidence, oxygen saturation (SpO2 ) > 90% has been widely used and accepted for ELGANs. Currently, SPO2 targeted ranges include SpO2 85% to 95%. Recent cohort studies suggest that the lower end of this ange may reduce ROP by up to 75% and CLD by upt to 60%., but the effect of the lower Sp O2 range on mortality and morbidity , and severe disability are uncertain. The hypothesis of this study are: 1) ELGANs randomized to SpO2 85-89% vs 91-95% have absolute risk reduction 4% (relative risk reduction 25%) in severe ROP and 10% (relative risk reduction 25%) in BPD. This study is part of a larg eorld wide network in Australia, US, Canada, and UK. Some other European countries as Norway,Finland and Germany have been invited to join. The US and Canadian part will each recruit 1200 children. From Norway we plan to recruit approximately 100-150 ELGANs. To test these hypothesis a multicenter, double masked trial recruting aprox 2500 infants. Norway, Finland and Germany are invited to join the Canadian part. The Australian part has been funded with 2.2mill Australian $ and the Canadian part has applied for 3,6 mill Can$ both over 5 years. In Norway we plan to recruit some neonatal intensive care units with access to a good opthalmological service



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