BOOST II: Benefits Of Oxygen Saturation Targeting Study
Which oxygen saturation level should we use for very premature infants? A randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants
NHMRC Clinical Trials Centre
1,200 participants
Mar 25, 2006
Interventional
Conditions
Summary
Oxygen is the commonest neonatal therapy. Unfortunately, both too much and too little oxygen may be harmful for very premature infants. We now measure the oxygen in a baby's blood by oxygen saturation but the optimum range in the first few weeks is unknown and no randomised controlled trial (RCT) has addressed this question. This proposal is for Australian arm of a major international study involving 5000 babies, born at less than 28 weeks, to address this question. Babies will be randomised to a higher or lower target range of oxygen saturation from birth (85-89% or 91-95%). For all oximeters staff will target a masked range of 88-92%. We will assess which of the two target ranges is associated with the best overall outcome, which is a composite measure of survival, disability on a standard test of neurodevelopment (Bayley scales), and visual function at 2 years of age.
Eligibility
Inclusion Criteria1
- a) born <28 weeks gestation b) less than 24 hours of agec) there is informed consent by parent(s) or legal guardian
Exclusion Criteria1
- a) There is a known congenital anomaly that could affect oxygenation or developmentb) attendance for follow-up for 2 years is judged unlikely.
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Interventions
Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)
Locations(1)
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ACTRN12605000055606