Tarnow-Mordi, W and Stenson, B and Kirby, A and Juszczak, E and Donoghoe, M and Deshpande, S and Morley, C and King, A and Doyle, LW and Fleck, BW and Davis, PG and Halliday, HL and Hague, W and Cairns, P and Darlow, BA and Fielder, AR and Gebski, V and Marlow, N and Simmer, K and Tin, W and Ghadge, A and Williams, C and Keech, A and Wardle, SP and Kecskes, Z and Kluckow, M and Gole, G and Evans, N and Malcolm, G and Luig, M and Wright, I and Stack, J and Tan, K and Pritchard, M and Gray, PH and Morris, S and Headley, B and Dargaville, P and Simes, RJ and Brocklehurst, P, BOOST-II Australia and United Kingdom Collaborative Groups, Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants, New England Journal of Medicine, 374, (8) pp. 749-760. ISSN 0028-4793 (2016) [Refereed Article]
© 2016 Massachusetts Medical Society. All rights reserved.
METHODS: In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial.
RESULTS: After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001).
CONCLUSIONS: Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses.
|Item Type:||Refereed Article|
|Research Division:||Medical and Health Sciences|
|Research Group:||Paediatrics and Reproductive Medicine|
|Objective Group:||Specific Population Health (excl. Indigenous Health)|
|Objective Field:||Child Health|
|UTAS Author:||Dargaville, P (Professor Peter Dargaville)|
|Web of Science® Times Cited:||78|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||105 View Download Statistics|
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