Benefits of Oxygen Saturation Targeting, trial II
(BOOST II)
Project manager–trial coordinator: Alpana Ghadge
Go to Benefits of Oxygen Saturation Targeting web site
Oxygen is the most common therapy for very premature infants. Doctors and nurses do not know the safe and effective level of oxygenation for these babies. Higher oxygen levels may increase retinopathy of prematurity (ROP) and respiratory problems, but lower oxygen levels may affect other long-term outcomes. A wide spectrum of opinion and practice currently exists.
BOOST II is a randomised, double-blind trial that will study the effects of using 2 different ranges of arterial oxygen saturation, 85–90% and 91–95%. Both are are currently used in normal practice. Patient safety will be monitored closely. Infants will have their development, vision and health assessed by specialists at 18–24 months of age (plus the prematurity period).
Eligibility
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less than 28 weeks' gestation
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less than 24 hours old
Each year in Australia, 850 children are born at less than 28 weeks' gestation and admitted to neonatal intensive care units. About 75% are discharged home alive. Despite a life expectancy of 70 years, they risk chronic lung disease, poor growth, respiratory illness, hospital readmission, visual deficits, cerebral palsy, sensorineural disability and cognitive, educational and behavioural impairment. They account for most of the costs and disability of neonatal intensive care. Their risk of visual deficit may be increasing.
This trial will answer important questions about the benefits and risks of higher compared with lower oxygen levels, and will improve the care of thousands of Australian children and millions more worldwide.
Study treatment
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Inspired oxygen to a target of 85–89% arterial oxygen saturation or 91–95% saturation
Main
outcome measures
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death or major disability at 2 years of age
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retinal surgery, neonatal chronic lung disease, growth impairment, use of health care resources