William O. Tarnow-Mordi, University of Sydney
Ben Stenson, Royal Infirmary of Edinburgh, UK
Adrienne Kirby, University of Sydney
Edmund Juszczak, University of Oxford
Mark Donoghoe, University of Sydney
Sanjeev Deshpande, Royal Shrewsbury Hospital
Colin J. Morley, Royal Women's Hospital
Andrew King, University of Oxford
Lex W. Doyle, Royal Women's Hospital
Brian W. Fleck, Princess Alexandra Eye Pavilion
Peter Davis, Royal Women's Hospital
Henry L. Halliday, Royal Jubilee Maternity Hospita
Wendy Hague, Nhmrc Clinical Trials Centre
Pamela Cairns, St. Michael's Hospital
Brian A. Darlow, University of Otago
Alistair R. Fielder, City University London
Val Gebski, Nhmrc Clinical Trials Centre
Neil Marlow, University College London
Karen Simmer, University of Western Australia
Win Tin, James Cook University Hospital
Alpana Ghadge, Nhmrc Clinical Trials Centre
Cathy Williams, University of Bristol
Anthony Keech, University of Sydney
Stephen P. Wardle, Nottingham University
Zsuzsoka Kecskes, Canberra Hospital
Martin Kluckow, Royal North Shore HospitalFollow
Glen Gole, University of Queensland
Nicholas Evans, University of Sydney
Girvan Malcolm, University of Sydney
Melissa Luig, Westmead Hospital
Ian M. R Wright, University of WollongongFollow
Jacqueline Stack, Liverpool Hospital
Kenneth Tan, Monash University
Margo Pritchard, Australian Catholic University
Peter H. Gray, Mater Mothers' Hospital
Scott Morris, Flinders University
Bevan Headley, Women's and Children's Hospital, Adelaide
Peter Dargaville, Royal Hobart Hospital
R John Simes, NHMRC Clinical Trials Centre
Peter Brocklehurst, University College London



Publication Details

Tarnow-Mordi, W., Stenson, B., Kirby, A., Juszczak, E., Donoghoe, M., Deshpande, S., Morley, C., King, A., Doyle, L. W., Fleck, B. W., Davis, P. G., Halliday, H. L., Hague, W., Cairns, P., Darlow, B. A., Fielder, A. R., Gebski, V., Marlow, N., Simmer, K., Tin, W., Ghadge, A., Williams, C., Keech, A., Wardle, S. P., Kecskes, Z., Kluckow, M., Gole, G., Evans, N., Malcolm, G., Luig, M., Wright, I., Stack, J., Tan, K., Pritchard, M., Gray, P. H., Morris, S., Headley, B., Dargaville, P., Simes, R. John. & Brocklehurst, P. (2016). Outcomes of two trials of oxygen-saturation targets in preterm infants. New England Journal of Medicine, 374 (8), 749-760.


BACKGROUND The safest ranges of oxygen saturation in preterm infants have been the subject of debate. 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.



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